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Document Number Document Title Language Last Update Link to clinivation
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USACD001 United States of America Regulatory Intelligence Dossier English Q1 - 2012  
USACD002 United States of America Guidance Documents Dossier English Q1 - 2012 R  T  N 
USACR001 United States of America Regulatory Intelligence Report English Q1 - 2012 R  T  N 
USADR001 United States of America Medical Device Distributors English Q1 - 2012 R  T  N 
USAFM001 Notice of Availability of Sample Electronic Product FDA Form 2767 English Q1 - 2012 R  T  N 
USAFM002 Mobile Radiographic Systems Field Test Record FDA Form 2784 English Q1 - 2012 R  T  N 
USAFM003 Above Table X-Ray Source Radiographic Systems FDA Form 2784 English Q1 - 2012 R  T  N 
USAFM004 Dental Radiographic Systems Field Test Record {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3} FDA Form 2785 English Q1 - 2012 R  T  N 
USAFM005 Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record FDA Form 2786 English Q1 - 2012 R  T  N 
USAFM006 Declaration of Products Subject to Radiation Control Standards FDA Form 2877 English Q1 - 2012 R  T  N 
USAFM007 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device FDA Form 3147 English Q1 - 2012 R  T  N 
USAFM008 Medical Device Reporting- Baseline Report- Part 1FDA Form 3417 English Q1 - 2012 R  T  N 
USAFM009 Medical Device Reporting Annual User Facility Report FDA Form 3419 English Q1 - 2012 R  T  N 
USAFM010 Government Entity Declaration FDA Form 3422 English Q1 - 2012 R  T  N 
USAFM011 Supplemental Data Sheet FDA Form 3427 English Q1 - 2012 R  T  N 
USAFM012 General Device Classification Questionnaire FDA Form 3429 English Q1 - 2012 R  T  N 
USAFM013 Certification: Financial Interest and Arrangements of Clinical Investigators FDA Form 3454 English Q1 - 2012 R  T  N 
USAFM014 Disclosure: Financial Interest and Arrangements of Clinical Investigators FDA Form 3455 English Q1 - 2012 R  T  N 
USAFM015 MedWatch: FDA Medical Product Reporting Program FDA Form 3500 English Q1 - 2012 R  T  N 
USAFM016 MedWatch: FDA Medical Products Reporting Program FDA Form 3500A English Q1 - 2012 R  T  N 
USAFM017 CDRH Submission Cover Sheet FDA Form 3514 English Q1 - 2012 R  T  N 
USAFM018 Infusion Pump Information Submission Report FDA Form 3571 English Q1 - 2012 R  T  N 
USAFM019 Supplementary Information Certificate to Foreign Government Requests FDA Form 3613 English Q1 - 2012 R  T  N 
USAFM020 Supplementary Information Certificate of Exportability Requests FDA Form 3613a English Q1 - 2012 R  T  N 
USAFM021 Supplementary Information Non-Clinical Research Use Only Certificate FDA Form 3613c English Q1 - 2012 R  T  N 
USAFM025 Medwatch FDA Form 3500A English Q1 - 2012 R  T  N 
USAFM026 Medwatch FDA Form 3500 English Q1 - 2012 R  T  N 
USAFM027 Q2 2011-FDA510(k)Implementation Plan English Q1 - 2012 R  T  N 
USAGD001 Guidance for Industry-Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses English Q1 - 2012 R  T  N 
USAGD002 Guidance for Industry and FDA Reviewers/Staff-Guidance for Cardiovascular Intravascular Filter 510(k) Submissions English Q1 - 2012 R  T  N 
USAGD003 Guidance for the Submission of 51 0(k) Premarket-Notifications for Electrocardiograph (ECG) Electrodes English Q1 - 2012 R  T  N 
USAGD004 Guidance for the Submission of 510(k) Premarket-Notifications for Electrocardiograph (ECG) Lead Switching Adaptor English Q1 - 2012 R  T  N 
USAGD005 Electrocardiograph Surface Electrode Tester English Q1 - 2012 R  T  N 
USAGD006 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants English Q1 - 2012 R  T  N 
USAGD007 Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Human Dura Mater English Q1 - 2012 R  T  N 
USAGD008 Guidance for Industry and FDA Staff-Surgical Masks - Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD009 Guidance for Industry and FDA Staff-Expedited Review of Premarket Submissions for Devices English Q1 - 2012 R  T  N 
USAGD011 Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside use in the Neonate Nursery English Q1 - 2012 R  T  N 
USAGD012 Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests English Q1 - 2012 R  T  N 
USAGD013 Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff English Q1 - 2012 R  T  N 
USAGD015 Guidance for the Content of Premarket Notifications for Penile Rigidity Implants English Q1 - 2012 R  T  N 
USAGD016 Medical Device Reporting ?CRemedial Action Exemption English Q1 - 2012 R  T  N 
USAGD017 Labeling Reusable Medical Devices For Reprocessing in Health Care Facilities: FDA Reviewer Guidance English Q1 - 2012 R  T  N 
USAGD018 New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff English Q1 - 2012 R  T  N 
USAGD019 Guidelines for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) English Q1 - 2012 R  T  N 
USAGD020 Guidance Document for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Intra-Articular Prosthetic Knee Ligament Devices English Q1 - 2012 R  T  N 
USAGD021 Guidelines for Evaluation of Fetal Clip Electrode English Q1 - 2012 R  T  N 
USAGD025 Needlesticks - Medical Device Reporting Guidance English Q1 - 2012 R  T  N 
USAGD026 Guide for Filing Annual Reports for X-Ray Components and Systems English Q1 - 2012 R  T  N 
USAGD027 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components English Q1 - 2012 R  T  N 
USAGD028 A Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems English Q1 - 2012 R  T  N 
USAGD029 Guide for Preparing Product Reports For Lasers and Products Containing Lasers English Q1 - 2012 R  T  N 
USAGD030 Compliance Guide for Laser Products English Q1 - 2012 R  T  N 
USAGD032 Color Additive Petitions English Q1 - 2012 R  T  N 
USAGD033 Premarket Approval Application Filing Review English Q1 - 2012 R  T  N 
USAGD034 Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Submerged (Underwater) Exercise Equipment English Q1 - 2012 R  T  N 
USAGD035 Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff English Q1 - 2012 R  T  N 
USAGD036 Medical Device Reporting ?C Alternative Summary Reporting (ASR) Program English Q1 - 2012 R  T  N 
USAGD038 Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry English Q1 - 2012 R  T  N 
USAGD039 Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes English Q1 - 2012 R  T  N 
USAGD040 Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Exercise Equipment English Q1 - 2012 R  T  N 
USAGD041 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices English Q1 - 2012 R  T  N 
USAGD042 Guidance Document for the Preparation of Premarket Notification [510(k)] Application for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles English Q1 - 2012 R  T  N 
USAGD043 Threshold Assessment of the Impact of a Requirements for Submission of Premarket Approval Applications for 31 Medical Devices English Q1 - 2012 R  T  N 
USAGD044 Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems English Q1 - 2012 R  T  N 
USAGD045 Updated 510(k) Sterility Review Guidance K90-1 English Q1 - 2012 R  T  N 
USAGD046 Guidance for Submission of Immunohistochemistry Applications to the FDA English Q1 - 2012 R  T  N 
USAGD047 Guidance on the Content and Organization of a Premarket Notification for a Medical Laser English Q1 - 2012 R  T  N 
USAGD048 Shelf Life of Medical Devices English Q1 - 2012 R  T  N 
USAGD049 Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices English Q1 - 2012 R  T  N 
USAGD050 Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers English Q1 - 2012 R  T  N 
USAGD051 Guideline on General Principles of Process Validation English Q1 - 2012 R  T  N 
USAGD053 FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions English Q1 - 2012 R  T  N 
USAGD054 Guidance for Industry General/Specific Intended Use English Q1 - 2012 R  T  N 
USAGD055 Quality Assurance Guidelines for Hemodialysis Devices English Q1 - 2012 R  T  N 
USAGD056 Thermal Endometrial Ablation Devices Submission Guidance For an Idea English Q1 - 2012 R  T  N 
USAGD058 Convenience Kits Interim Regulatory Guidance English Q1 - 2012 R  T  N 
USAGD059 Off-The-Shelf Software Use in Medical Devices English Q1 - 2012 R  T  N 
USAGD060 Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physician Office Laboratory and Home Use English Q1 - 2012 R  T  N 
USAGD061 Changes in Device Classification English Q1 - 2012 R  T  N 
USAGD062 Regulation of Medical Devices: Background Information for International Officials English Q1 - 2012 R  T  N 
USAGD064 Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems English Q1 - 2012 R  T  N 
USAGD065 Immunotoxicity Testing Guidance English Q1 - 2012 R  T  N 
USAGD066 Spinal System 510(k)s English Q1 - 2012 R  T  N 
USAGD067 General Considerations in the Design of Clinical Studies for Pain-Alleviating Devices English Q1 - 2012 R  T  N 
USAGD068 Guidelines for Evaluation of Non-Drug New IUDs English Q1 - 2012 R  T  N 
USAGD069 Guidance for the Submission of 510(k)??s for Solid State X-ray Imaging Devices English Q1 - 2012 R  T  N 
USAGD071 Draft Guidance for the Preparation of a Premarket Notification For Extended Laparoscopy Devices (ELD) English Q1 - 2012 R  T  N 
USAGD072 Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement English Q1 - 2012 R  T  N 
USAGD073 Real-Time Premarket Approval Application (PMA) Supplements English Q1 - 2012 R  T  N 
USAGD074 Premarket Notifications (510(k)) Guidance Document for Contact Lens Care Products English Q1 - 2012 R  T  N 
USAGD075 Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion Hydrobaths English Q1 - 2012 R  T  N 
USAGD076 Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables English Q1 - 2012 R  T  N 
USAGD077 Imports Radiation Producing Electronic Products English Q1 - 2012 R  T  N 
USAGD078 Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communication Systems (Powered and Non-Powered) and Powered Environmental Control Systems English Q1 - 2012 R  T  N 
USAGD079 Review Criteria for Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 English Q1 - 2012 R  T  N 
USAGD081 Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens English Q1 - 2012 R  T  N 
USAGD082 Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators English Q1 - 2012 R  T  N 
USAGD083 Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices English Q1 - 2012 R  T  N 
USAGD084 Reviewer Guidance for Automatic X-Ray Film Processor 510(k) Premarket Notifications English Q1 - 2012 R  T  N 
USAGD086 Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve English Q1 - 2012 R  T  N 
USAGD087 Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices English Q1 - 2012 R  T  N 
USAGD088 Guidance for Industry: FDA Export Certificates English Q1 - 2012 R  T  N 
USAGD089 Bundling Multiple Devices or Multiple Indications in a Single Submission-Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD091 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use English Q1 - 2012 R  T  N 
USAGD092 Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002 - Guidance for Industry, FDA Staff, and FDA-Accredited Third-Parties English Q1 - 2012 R  T  N 
USAGD093 Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD094 User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD095 User Fees and Refunds for Premarket Notification Submissions (510(k) - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD096 Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties English Q1 - 2012 R  T  N 
USAGD097 Alternative to Certain Prescription Device Labeling Requirements English Q1 - 2012 R  T  N 
USAGD098 Civil Money Penalty Policy English Q1 - 2012 R  T  N 
USAGD099 Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices - Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD100 General Principles of Software Validation; Final Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD101 PMA Review Statistical Checklist English Q1 - 2012 R  T  N 
USAGD102 Perspectives on Clinical Studies for Medical Device Submissions (Statistical) English Q1 - 2012 R  T  N 
USAGD103 Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations English Q1 - 2012 R  T  N 
USAGD104 Common Problems: Baseline Reports and MedWatch Form 3500A (letter to manufacturers updated) English Q1 - 2012 R  T  N 
USAGD105 Comparison Chart: 1996 Quality System Regulation vs. 1978 Good Manufacturing Practices Regulation vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 English Q1 - 2012 R  T  N 
USAGD106 DRAFT Guidance for Staff, Industry and U.S./EU CABs Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7 June 29, 2000 English Q1 - 2012 R  T  N 
USAGD107 DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7 June 29, 2000 English Q1 - 2012 R  T  N 
USAGD108 Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure English Q1 - 2012 R  T  N 
USAGD109 Open Door Operation of Microwave Ovens as a Result of Oven Miswiring English Q1 - 2012 R  T  N 
USAGD110 Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002 English Q1 - 2012 R  T  N 
USAGD111 Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers English Q1 - 2012 R  T  N 
USAGD112 Standard Specification for Rubber Contraceptives (Condoms) English Q1 - 2012 R  T  N 
USAGD113 Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices English Q1 - 2012 R  T  N 
USAGD114 Policy on Warning Label Required on Sunlamp Products English Q1 - 2012 R  T  N 
USAGD115 Procedures for Laboratory Compliance Testing of Television Receivers English Q1 - 2012 R  T  N 
USAGD116 Policy on Lamp Compatibility (sunlamps) English Q1 - 2012 R  T  N 
USAGD117 Industry Representatives on Scientific Panel English Q1 - 2012 R  T  N 
USAGD118 All U.S. Condom Manufacturers, Importers and Repackagers English Q1 - 2012 R  T  N 
USAGD119 Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87) English Q1 - 2012 R  T  N 
USAGD120 Master Files Part III; Guidance on Scientific and Technical Information English Q1 - 2012 R  T  N 
USAGD121 Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II English Q1 - 2012 R  T  N 
USAGD122 Color Additive Status List (Inspection Operations Manual) English Q1 - 2012 R  T  N 
USAGD123 Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) English Q1 - 2012 R  T  N 
USAGD124 Premarket Testing Guidelines for Female Barrier Contraceptive Devices also intended to prevent sexually transmitted diseases English Q1 - 2012 R  T  N 
USAGD125 Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases English Q1 - 2012 R  T  N 
USAGD126 Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies English Q1 - 2012 R  T  N 
USAGD127 Review Criteria for Devices Intended for the Detection of Hepatitis B (e) Antigen and Antibody to Hbe English Q1 - 2012 R  T  N 
USAGD128 Preamendment Class III Devices English Q1 - 2012 R  T  N 
USAGD129 SMDA Changes - Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert English Q1 - 2012 R  T  N 
USAGD130 Guidance for Peak Flow Meters for Over-the-Counter Sale English Q1 - 2012 R  T  N 
USAGD131 Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents English Q1 - 2012 R  T  N 
USAGD132 Important Information About Rophae Intraocular Lenses English Q1 - 2012 R  T  N 
USAGD133 General Guidance Document: Non-Invasive Pulse Oximeter English Q1 - 2012 R  T  N 
USAGD134 Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities English Q1 - 2012 R  T  N 
USAGD135 Draft Emergency Resuscitator Guidance English Q1 - 2012 R  T  N 
USAGD136 Classified Convenience Kits English Q1 - 2012 R  T  N 
USAGD137 Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson English Q1 - 2012 R  T  N 
USAGD138 Medwatch FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting English Q1 - 2012 R  T  N 
USAGD139 CDRH 510(k) Refuse to Accept Policy - (updated Checklist 3/14/1995) English Q1 - 2012 R  T  N 
USAGD140 CDRH Investigational Device Exemption (IDE) Refuse to Accept Policy English Q1 - 2012 R  T  N 
USAGD141 Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] English Q1 - 2012 R  T  N 
USAGD142 Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes English Q1 - 2012 R  T  N 
USAGD143 Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities English Q1 - 2012 R  T  N 
USAGD144 Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers English Q1 - 2012 R  T  N 
USAGD145 Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard) English Q1 - 2012 R  T  N 
USAGD146 Battery Guidance English Q1 - 2012 R  T  N 
USAGD147 Guideline for the Manufacture of In Vitro Diagnostic Products English Q1 - 2012 R  T  N 
USAGD148 Draft 510(K) Submission Requirements for Peak Flow Meters English Q1 - 2012 R  T  N 
USAGD149 Draft Reviewer Guidance on Face Masks and Shield for CPR English Q1 - 2012 R  T  N 
USAGD150 Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement English Q1 - 2012 R  T  N 
USAGD151 Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D.,M.D English Q1 - 2012 R  T  N 
USAGD152 Guidance for the Content of Premarket Notifications for Urine Drainage Bags English Q1 - 2012 R  T  N 
USAGD153 Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims English Q1 - 2012 R  T  N 
USAGD154 Points to Consider for Cervical Cytology Devices English Q1 - 2012 R  T  N 
USAGD155 Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance English Q1 - 2012 R  T  N 
USAGD156 Coronary and Cerebrovascular Guidewire Guidance English Q1 - 2012 R  T  N 
USAGD157 Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters English Q1 - 2012 R  T  N 
USAGD158 Guidance Document for Testing Non-Articulating, Mechanically Locked, Modular Implant Components English Q1 - 2012 R  T  N 
USAGD159 Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions English Q1 - 2012 R  T  N 
USAGD160 Draft Reviewer Guidance for Ventilators English Q1 - 2012 R  T  N 
USAGD162 Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices English Q1 - 2012 R  T  N 
USAGD163 Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators English Q1 - 2012 R  T  N 
USAGD164 Indications for Use Statement English Q1 - 2012 R  T  N 
USAGD165 Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 English Q1 - 2012 R  T  N 
USAGD166 A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use English Q1 - 2012 R  T  N 
USAGD167 Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k English Q1 - 2012 R  T  N 
USAGD168 Medical Device Reporting for User Facilities English Q1 - 2012 R  T  N 
USAGD169 Medical Device Reporting: An Overview English Q1 - 2012 R  T  N 
USAGD170 Guidance Document For Testing Bone Anchor Devices English Q1 - 2012 R  T  N 
USAGD171 Manufacturers and Initial Distributors of Hemodialyzers English Q1 - 2012 R  T  N 
USAGD172 Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] English Q1 - 2012 R  T  N 
USAGD173 Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications English Q1 - 2012 R  T  N 
USAGD174 Do It By Design - An Introduction to Human Factors in Medical Devices English Q1 - 2012 R  T  N 
USAGD175 Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) English Q1 - 2012 R  T  N 
USAGD176 Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) English Q1 - 2012 R  T  N 
USAGD177 Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) English Q1 - 2012 R  T  N 
USAGD178 Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators English Q1 - 2012 R  T  N 
USAGD179 Reviewers Guidance Checklist for Orthopedic External Fixation Devices English Q1 - 2012 R  T  N 
USAGD180 Reviewers Guidance Checklist for Intramedullary Rods English Q1 - 2012 R  T  N 
USAGD181 Medical Device Reporting for Manufacturers English Q1 - 2012 R  T  N 
USAGD182 Design Control Guidance for Medical Device Manufacturers English Q1 - 2012 R  T  N 
USAGD183 Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis English Q1 - 2012 R  T  N 
USAGD185 ORDB 510(k) Sterility Review Guidance English Q1 - 2012 R  T  N 
USAGD186 Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) English Q1 - 2012 R  T  N 
USAGD187 Discussion Points for Expansion of the Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers Draft Document English Q1 - 2012 R  T  N 
USAGD188 Guidance on IDE Policies and Procedures; Final English Q1 - 2012 R  T  N 
USAGD189 Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final English Q1 - 2012 R  T  N 
USAGD190 Medical Device Appeals and Complaints: A Guidance on Dispute Resolution English Q1 - 2012 R  T  N 
USAGD191 Guidance for Industry In Vitro Diagnostic Creatinine Test System; Final English Q1 - 2012 R  T  N 
USAGD192 Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; Final English Q1 - 2012 R  T  N 
USAGD193 Guidance for Industry In Vitro Diagnostic Sodium Test System; Final English Q1 - 2012 R  T  N 
USAGD194 Guidance for Industry In Vitro Diagnostic Potassium Test System; Final English Q1 - 2012 R  T  N 
USAGD195 Guidance for Industry In Vitro Diagnostic Chloride Test System; Final English Q1 - 2012 R  T  N 
USAGD196 Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Final English Q1 - 2012 R  T  N 
USAGD197 Guidance for Industry In Vitro Diagnostic Glucose Test System; Final English Q1 - 2012 R  T  N 
USAGD198 Slit Lamp Guidance; Final English Q1 - 2012 R  T  N 
USAGD199 Ophthalmoscope Guidance English Q1 - 2012 R  T  N 
USAGD200 Retinoscope Guidance; Final English Q1 - 2012 R  T  N 
USAGD201 Guidance Document for Surgical Lamp 510(k)s; Final English Q1 - 2012 R  T  N 
USAGD202 Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final English Q1 - 2012 R  T  N 
USAGD203 OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final English Q1 - 2012 R  T  N 
USAGD204 Dental Impression Materials - Premarket Notification; Final English Q1 - 2012 R  T  N 
USAGD205 Guidance Document for Powered Suction Pump 510(k)s English Q1 - 2012 R  T  N 
USAGD206 Guidance Document for Nonprescription Sunglasses; Final English Q1 - 2012 R  T  N 
USAGD207 SMDA to FDAMA: Guidance on FDA Transition Plan for Existing Postmarket Surveillance English Q1 - 2012 R  T  N 
USAGD208 Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final English Q1 - 2012 R  T  N 
USAGD209 Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final English Q1 - 2012 R  T  N 
USAGD210 Harmonic Imaging with/without Contrast - Premarket Notification; Final English Q1 - 2012 R  T  N 
USAGD211 Aqueous Shunts - 510(k) Submissions; Final English Q1 - 2012 R  T  N 
USAGD212 Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final English Q1 - 2012 R  T  N 
USAGD213 Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final English Q1 - 2012 R  T  N 
USAGD214 Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final English Q1 - 2012 R  T  N 
USAGD215 Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final English Q1 - 2012 R  T  N 
USAGD216 Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) English Q1 - 2012 R  T  N 
USAGD217 Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft English Q1 - 2012 R  T  N 
USAGD218 Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final English Q1 - 2012 R  T  N 
USAGD219 Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final English Q1 - 2012 R  T  N 
USAGD220 Guidance for Dermabrasion Devices; Final English Q1 - 2012 R  T  N 
USAGD221 Guidance on 510(k) Submissions for Keratoprostheses, Final English Q1 - 2012 R  T  N 
USAGD222 Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects English Q1 - 2012 R  T  N 
USAGD223 Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s]; Final English Q1 - 2012 R  T  N 
USAGD224 Guidance Document for Powered Muscle Stimulator 510(k)s; Final English Q1 - 2012 R  T  N 
USAGD225 Guidance on Labeling for Laboratory Tests; Draft English Q1 - 2012 R  T  N 
USAGD226 Draft Medical Glove Guidance Manual English Q1 - 2012 R  T  N 
USAGD227 Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval English Q1 - 2012 R  T  N 
USAGD228 Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables English Q1 - 2012 R  T  N 
USAGD229 Regulating In Vitro Diagnostic Device (IVD) Studies English Q1 - 2012 R  T  N 
USAGD230 Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing English Q1 - 2012 R  T  N 
USAGD231 Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final English Q1 - 2012 R  T  N 
USAGD232 Guidance Document for the Preparation of IDEs for Spinal Systems English Q1 - 2012 R  T  N 
USAGD233 Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final English Q1 - 2012 R  T  N 
USAGD234 Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft English Q1 - 2012 R  T  N 
USAGD235 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final English Q1 - 2012 R  T  N 
USAGD236 Guidance on the Use of Standards in Substantial Equivalence Determinations; Final English Q1 - 2012 R  T  N 
USAGD237 Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment English Q1 - 2012 R  T  N 
USAGD238 Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final English Q1 - 2012 R  T  N 
USAGD239 Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final English Q1 - 2012 R  T  N 
USAGD240 Class II Special Controls Guidance Document for Clitoral Engorgement Devices English Q1 - 2012 R  T  N 
USAGD241 Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval Applications English Q1 - 2012 R  T  N 
USAGD242 The Mammography Quality Standards Act Final Regulations Document 3 English Q1 - 2012 R  T  N 
USAGD243 Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management English Q1 - 2012 R  T  N 
USAGD245 Guidance on Amended Procedures for Advisory Panel Meetings; Final English Q1 - 2012 R  T  N 
USAGD246 Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s English Q1 - 2012 R  T  N 
USAGD247 Surveillance and Detention Without Physical Examination of Surgeon and/or Patient Examination Gloves; Guidance for Industry - Draft English Q1 - 2012 R  T  N 
USAGD248 Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources English Q1 - 2012 R  T  N 
USAGD249 Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi English Q1 - 2012 R  T  N 
USAGD250 Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 English Q1 - 2012 R  T  N 
USAGD251 Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms English Q1 - 2012 R  T  N 
USAGD252 Guidance for Administrative Procedures for CLIA Categorization English Q1 - 2012 R  T  N 
USAGD253 Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals English Q1 - 2012 R  T  N 
USAGD254 Guidance for Industry: Labeling for Electronic Anti-Theft Systems English Q1 - 2012 R  T  N 
USAGD255 Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications English Q1 - 2012 R  T  N 
USAGD256 Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis English Q1 - 2012 R  T  N 
USAGD257 Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions English Q1 - 2012 R  T  N 
USAGD258 Guidance Document for Vascular Prostheses 510(k) Submissions English Q1 - 2012 R  T  N 
USAGD259 Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD260 Guidance Document for Dura Substitute Devices; Final Guidance for Industry English Q1 - 2012 R  T  N 
USAGD261 Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD262 Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD263 Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD264 Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry English Q1 - 2012 R  T  N 
USAGD266 Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD267 Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD268 Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD269 CDRH Manual for Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff English Q1 - 2012 R  T  N 
USAGD270 Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD271 Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD272 Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD273 Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD274 Implementation of the Biomaterials Access Assurance Act of 1998; Draft Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD275 Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD276 Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use English Q1 - 2012 R  T  N 
USAGD278 Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA - Laser Notice 51 English Q1 - 2012 R  T  N 
USAGD279 Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff English Q1 - 2012 R  T  N 
USAGD280 Information for Keratome Manufacturers Regarding LASIK; Final Guidance for Industry English Q1 - 2012 R  T  N 
USAGD282 Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD283 Frequently Asked Questions about the Reprocessing and Reuse of Single Use Devices by Third Party and Hospital Reprocessors; Final Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD284 Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD285 Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD287 Compliance Guidance - The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD288 Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD289 Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD290 Sterilized Convenience Kits for Clinical and Surgical Use; Final Guidance for Industry English Q1 - 2012 R  T  N 
USAGD291 Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff English Q1 - 2012 R  T  N 
USAGD292 Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD293 Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD294 Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis English Q1 - 2012 R  T  N 
USAGD295 Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry English Q1 - 2012 R  T  N 
USAGD296 Cardiac Ablation Catheters Generic Arrhythmia Indications for Use Guidance for Industry English Q1 - 2012 R  T  N 
USAGD297 Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD298 Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD299 Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD300 Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD301 The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry English Q1 - 2012 R  T  N 
USAGD302 Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD303 Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD304 Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD305 Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD306 Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD307 Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD309 Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD310 User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry English Q1 - 2012 R  T  N 
USAGD311 Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD312 Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD313 Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD314 Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD315 510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD316 Breath Nitric Oxide Test System - Class II Special Controls Guidance Document English Q1 - 2012 R  T  N 
USAGD317 Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD318 Frequently Asked Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions - Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors English Q1 - 2012 R  T  N 
USAGD319 Class II Special Controls Guidance Document: Breast Lesion Documentation System - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD320 Implantable Middle Ear Hearing Device; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD321 Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD323 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus English Q1 - 2012 R  T  N 
USAGD324 Class II Special Controls Guidance Document: Endotoxin Assay English Q1 - 2012 R  T  N 
USAGD325 Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD326 Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD327 Guidance for Industry and FDA Staff; Replacement Reagent and Instrument Family Policy English Q1 - 2012 R  T  N 
USAGD328 Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD329 Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD332 Consumer-Directed Broadcast Advertising of Restricted Devices English Q1 - 2012 R  T  N 
USAGD334 Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD335 Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD336 Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon??s Glove - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD337 Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD338 Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD339 Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD340 FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD341 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys English Q1 - 2012 R  T  N 
USAGD342 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys English Q1 - 2012 R  T  N 
USAGD343 Class II Special Controls Guidance Document: External Penile Rigidity Devices English Q1 - 2012 R  T  N 
USAGD344 Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices English Q1 - 2012 R  T  N 
USAGD345 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Sirolimus Test Systems English Q1 - 2012 R  T  N 
USAGD346 Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA English Q1 - 2012 R  T  N 
USAGD347 A Suggested Approach to Resolving Least Burdensome Issues English Q1 - 2012 R  T  N 
USAGD349 Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD351 Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff English Q1 - 2012 R  T  N 
USAGD352 Premarket Notification [510(k)] Status Request Form English Q1 - 2012 R  T  N 
USAGD353 Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) English Q1 - 2012 R  T  N 
USAGD354 Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori English Q1 - 2012 R  T  N 
USAGD355 Latex Labeling Letter (Johnson) English Q1 - 2012 R  T  N 
USAGD356 Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD357 Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD358 Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) English Q1 - 2012 R  T  N 
USAGD359 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems English Q1 - 2012 R  T  N 
USAGD360 Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry - Class II Special Controls Guidance Document English Q1 - 2012 R  T  N 
USAGD361 Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD362 Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators English Q1 - 2012 R  T  N 
USAGD363 Heated Humidifier Review Guidance English Q1 - 2012 R  T  N 
USAGD364 Guidance for Industry - Review Criteria for Assessment of C - Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays English Q1 - 2012 R  T  N 
USAGD365 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays English Q1 - 2012 R  T  N 
USAGD366 Guidance for Industry and FDA Staff - Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices English Q1 - 2012 R  T  N 
USAGD367 Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry English Q1 - 2012 R  T  N 
USAGD368 Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD369 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays English Q1 - 2012 R  T  N 
USAGD370 Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final English Q1 - 2012 R  T  N 
USAGD371 Guidance for Testing MR Interaction with Aneurysm Clips English Q1 - 2012 R  T  N 
USAGD372 Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDA English Q1 - 2012 R  T  N 
USAGD373 Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing) English Q1 - 2012 R  T  N 
USAGD374 A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD375 Letter to Manufacturers of Falloposcopes English Q1 - 2012 R  T  N 
USAGD376 Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests English Q1 - 2012 R  T  N 
USAGD377 Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD378 Certification Statement for the Impact Resistance Test English Q1 - 2012 R  T  N 
USAGD379 Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD380 Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm English Q1 - 2012 R  T  N 
USAGD381 Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan English Q1 - 2012 R  T  N 
USAGD382 #D95-2, Attachment A (Interagency Agreement between FDA & HCFA) English Q1 - 2012 R  T  N 
USAGD383 The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9 - Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD384 Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays English Q1 - 2012 R  T  N 
USAGD385 #D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA) English Q1 - 2012 R  T  N 
USAGD386 HCFA Reimbursement Categorization Determinations for FDA-approved IDEs English Q1 - 2012 R  T  N 
USAGD387 Guidance for Industry and FDA Staff - Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA English Q1 - 2012 R  T  N 
USAGD388 In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final English Q1 - 2012 R  T  N 
USAGD389 The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #11 - Guidance for Industry, MQSA Inspectors, and FDA Staff English Q1 - 2012 R  T  N 
USAGD390 Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software English Q1 - 2012 R  T  N 
USAGD391 Guidance for Industry and FDA Staff - Class II Special Controls Document: Oral Rinse to Reduce the Adhesion of Dental Plaque English Q1 - 2012 R  T  N 
USAGD392 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems English Q1 - 2012 R  T  N 
USAGD393 The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD394 Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD395 Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD396 CFTR Gene Mutation Detection Systems - Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document English Q1 - 2012 R  T  N 
USAGD397 Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems English Q1 - 2012 R  T  N 
USAGD398 Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD399 Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications English Q1 - 2012 R  T  N 
USAGD400 The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD401 Dental Curing Lights - Premarket Notification [510(k)] Submissions -Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD402 Draft Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions English Q1 - 2012 R  T  N 
USAGD403 Dental Cements - Premarket Notification; Final English Q1 - 2012 R  T  N 
USAGD404 Letter to Ophthalmologists about Lasers for Refractive Surgery English Q1 - 2012 R  T  N 
USAGD405 Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs English Q1 - 2012 R  T  N 
USAGD406 Bone Sonometers - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD407 Implantable Intra-Aneurysm Pressure Measurement System - Class II Special Controls Guidance Document English Q1 - 2012 R  T  N 
USAGD408 Guidance for Industry and FDA Staff - Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54) English Q1 - 2012 R  T  N 
USAGD409 Design Control Guidance for Medical Device Manufacturers English Q1 - 2012 R  T  N 
USAGD410 Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final English Q1 - 2012 R  T  N 
USAGD411 Letter: Notice to Manufacturers of Bone Mineral Densitometers English Q1 - 2012 R  T  N 
USAGD412 Tinnitus Masker Devices - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD413 Draft Guidance for Industry and FDA Staff - Pharmacogenetic Tests and Genetic Tests for Heritable Markers English Q1 - 2012 R  T  N 
USAGD414 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems English Q1 - 2012 R  T  N 
USAGD415 Human Factors Points to Consider for IDE Devices English Q1 - 2012 R  T  N 
USAGD416 A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications English Q1 - 2012 R  T  N 
USAGD417 30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket 98D-0080); Final English Q1 - 2012 R  T  N 
USAGD418 Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device English Q1 - 2012 R  T  N 
USAGD419 Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD420 Reagents for Detection of Specific Novel Influenza A Viruses : Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document English Q1 - 2012 R  T  N 
USAGD421 Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions English Q1 - 2012 R  T  N 
USAGD422 Uniform Contraceptive Labeling; Final English Q1 - 2012 R  T  N 
USAGD423 Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD425 Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD426 Recommended Clinical Study Design for Ventricular Tachycardia Ablation English Q1 - 2012 R  T  N 
USAGD427 Frequently Asked Questions on the New 510(k) Paradigm; Final English Q1 - 2012 R  T  N 
USAGD428 The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #10 - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD429 Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD430 Instrumentation for Clinical Multiplex Test Systems - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD431 Labeling for Male Condoms Made of Natural Rubber Latex - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD432 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Olfactory Test Device English Q1 - 2012 R  T  N 
USAGD433 Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD435 Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final English Q1 - 2012 R  T  N 
USAGD436 Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final English Q1 - 2012 R  T  N 
USAGD437 Letter to Medical Device Manufacturer on Pentium processors English Q1 - 2012 R  T  N 
USAGD438 Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD439 Drug Metabolizing Enzyme Genotyping System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD440 Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD441 Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s;Final Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD442 510(k) "Substantial Equivalence" Decision-making Process (Overview) English Q1 - 2012 R  T  N 
USAGD443 Letter to: Medical Device Industry Endoscopy and Laparoscopy Accessories English Q1 - 2012 R  T  N 
USAGD444 Dental Handpiece Sterilization English Q1 - 2012 R  T  N 
USAGD445 Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers English Q1 - 2012 R  T  N 
USAGD446 Guidance for Industry and FDA Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers English Q1 - 2012 R  T  N 
USAGD447 Medwatch Medical Device Reporting Code Instructions English Q1 - 2012 R  T  N 
USAGD448 Letter to Manufacturers/Repackers Using Cotton English Q1 - 2012 R  T  N 
USAGD449 Impact Resistant Lenses: Questions and Answers English Q1 - 2012 R  T  N 
USAGD450 Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy English Q1 - 2012 R  T  N 
USAGD451 Draft Document: Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use English Q1 - 2012 R  T  N 
USAGD452 A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use English Q1 - 2012 R  T  N 
USAGD453 Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care Professionals English Q1 - 2012 R  T  N 
USAGD454 Center for Devices and Radiological Health Office of Device Evaluation Division of Gastroenterology/Urology and General Use Devices Guidance on 510(k) Submissions for Implanted Infusion Ports English Q1 - 2012 R  T  N 
USAGD455 Implantable Pacemaker Testing Guidance English Q1 - 2012 R  T  N 
USAGD456 PBL and Other Changes to the Performance Standard; Small Target Angle X-Ray Tubes; Maximum EER and Large Image Intensifiers English Q1 - 2012 R  T  N 
USAGD457 Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products English Q1 - 2012 R  T  N 
USAGD458 Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties English Q1 - 2012 R  T  N 
USAGD459 Guidance for Industry ??Help-Seeking?? and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms English Q1 - 2012 R  T  N 
USAGD460 FDA policy on exhibiting medical devices prior to FDA marketing clearance English Q1 - 2012 R  T  N 
USAGD474 Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) English Q1 - 2012 R  T  N 
USAGD475 Inspection of Medical Device Manufacturers English Q1 - 2012 R  T  N 
USAGD491 Interactive Review for Medical Device Submissions Guidance English Q1 - 2012 R  T  N 
USAGD492 Expedited Review of Premarket Submissions for Devices Guidance English Q1 - 2012 R  T  N 
USAGD493 Decorative, Non-corrective Contact Lenses English Q1 - 2012 R  T  N 
USAGD494 Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography English Q1 - 2012 R  T  N 
USAGD495 Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays English Q1 - 2012 R  T  N 
USAGD496 Guidance for Industry, MQSA Inspectors, and FDA - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12 English Q1 - 2012 R  T  N 
USAGD497 Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices English Q1 - 2012 R  T  N 
USAGD498 Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA English Q1 - 2012 R  T  N 
USAGD499 Guidance for Industry and FDA Staff - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests English Q1 - 2012 R  T  N 
USAGD500 Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD501 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays English Q1 - 2012 R  T  N 
USAGD502 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems English Q1 - 2012 R  T  N 
USAGD503 Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD504 In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD505 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis English Q1 - 2012 R  T  N 
USAGD506 Guidance for Industry and FDA Staff: Performance Standard for Diagnostic X-Ray Systems and Their Major Components; (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide English Q1 - 2012 R  T  N 
USAGD507 Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material English Q1 - 2012 R  T  N 
USAGD508 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device English Q1 - 2012 R  T  N 
USAGD509 Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices English Q1 - 2012 R  T  N 
USAGD510 Guidance for Industry and FDA Staff - Pharmacogenetic Tests and Genetic Tests for Heritable Markers English Q1 - 2012 R  T  N 
USAGD511 Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission English Q1 - 2012 R  T  N 
USAGD512 Guidance for Industry and FDA Staff - Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50) English Q1 - 2012 R  T  N 
USAGD513 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies English Q1 - 2012 R  T  N 
USAGD514 Draft Guidance for Industry - Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage English Q1 - 2012 R  T  N 
USAGD515 Draft Guidance for Industry and FDA Staff - Pulse Oximeters - Premarket Notification Submissions [510(k)s] English Q1 - 2012 R  T  N 
USAGD516 Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents English Q1 - 2012 R  T  N 
USAGD517 Guidance for Industry and FDA Staff - Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs) English Q1 - 2012 R  T  N 
USAGD518 Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 English Q1 - 2012 R  T  N 
USAGD519 Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays English Q1 - 2012 R  T  N 
USAGD520 Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order English Q1 - 2012 R  T  N 
USAGD521 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology English Q1 - 2012 R  T  N 
USAGD522 Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices English Q1 - 2012 R  T  N 
USAGD523 Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions English Q1 - 2012 R  T  N 
USAGD524 Guidance for Industry and FDA Staff - CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition English Q1 - 2012 R  T  N 
USAGD525 Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses English Q1 - 2012 R  T  N 
USAGD526 Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards English Q1 - 2012 R  T  N 
USAGD527 Guidance for Industry and FDA Staff - Frequently Asked Questions on Recognition of Consensus Standards English Q1 - 2012 R  T  N 
USAGD528 Guidance for Industry and FDA Staff - Compliance Guide for Cabinet X-Ray Systems English Q1 - 2012 R  T  N 
USAGD529 Guidance for Industry and FDA Staff - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) English Q1 - 2012 R  T  N 
USAGD530 Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes English Q1 - 2012 R  T  N 
USAGD531 Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD532 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System English Q1 - 2012 R  T  N 
USAGD533 Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions English Q1 - 2012 R  T  N 
USAGD534 Draft Guidance for Industry and FDA Staff: Impact-Resistant Lenses: Questions and Answers English Q1 - 2012 R  T  N 
USAGD535 Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle English Q1 - 2012 R  T  N 
USAGD536 Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program English Q1 - 2012 R  T  N 
USAGD537 Guidance for Industry and FDA Staff - The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations English Q1 - 2012 R  T  N 
USAGD538 Guidance for Industry and FDA Staff - Medical Glove Guidance Manual English Q1 - 2012 R  T  N 
USAGD539 Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices English Q1 - 2012 R  T  N 
USAGD540 Draft Guidance for Industry and FDA Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses English Q1 - 2012 R  T  N 
USAGD541 Guidance for Industry and FDA Staff: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD542 Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products English Q1 - 2012 R  T  N 
USAGD543 Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements English Q1 - 2012 R  T  N 
USAGD545 Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (Companion Document) English Q1 - 2012 R  T  N 
USAGD546 Guidance for Industry: Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies English Q1 - 2012 R  T  N 
USAGD547 Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs English Q1 - 2012 R  T  N 
USAGD548 Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis English Q1 - 2012 R  T  N 
USAGD549 Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions English Q1 - 2012 R  T  N 
USAGD550 Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization English Q1 - 2012 R  T  N 
USAGD551 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays English Q1 - 2012 R  T  N 
USAGD552 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin English Q1 - 2012 R  T  N 
USAGD553 Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System English Q1 - 2012 R  T  N 
USAGD554 Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions English Q1 - 2012 R  T  N 
USAGD555 Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters English Q1 - 2012 R  T  N 
USAGD556 FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD557 Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] English Q1 - 2012 R  T  N 
USAGD558 Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Condoms English Q1 - 2012 R  T  N 
USAGD559 Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves English Q1 - 2012 R  T  N 
USAGD560 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers English Q1 - 2012 R  T  N 
USAGD561 Guidance for Industry, FDA, and Foreign Governments - FY 2009 Medical Device User Fee Small Business Qualification and Certification English Q1 - 2012 R  T  N 
USAGD562 Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers English Q1 - 2012 R  T  N 
USAGD563 Guidance for Industry and FDA Staff: Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter English Q1 - 2012 R  T  N 
USAGD564 Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff English Q1 - 2012 R  T  N 
USAGD565 Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment English Q1 - 2012 R  T  N 
USAGD566 Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers English Q1 - 2012 R  T  N 
USAGD567 Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence English Q1 - 2012 R  T  N 
USAGD568 Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process English Q1 - 2012 R  T  N 
USAGD569 Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile English Q1 - 2012 R  T  N 
USAGD570 Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander English Q1 - 2012 R  T  N 
USAGD571 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 English Q1 - 2012 R  T  N 
USAGD572 Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use English Q1 - 2012 R  T  N 
USAGD573 Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA English Q1 - 2012 R  T  N 
USAGD574 Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices English Q1 - 2012 R  T  N 
USAGD575 Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide English Q1 - 2012 R  T  N 
USAGD576 Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions English Q1 - 2012 R  T  N 
 

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