Withdrawn Guidance
This page lists CDRH guidance documents that have been withdrawn and no longer represent FDA's current thinking.
These documents are presented for historical purposes only.
Withdrawn CDRH Guidance Documents
Title | Issue Date |
Withdrawal Date |
---|---|---|
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices | 12/01/1983 | 10/23/2020 |
Preamendments Class III Strategy | 04/19/1994 | 10/23/2020 |
Alternative to Certain Prescription Device Labeling Requirements - Guidance for Industry | 01/21/2000 | 10/23/2020 |
Reprocessing and Reuse of Single-Use Devices - Guidance for Industry and FDA Reviewers | 02/08/2000 | 10/23/2020 |
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals - Guidance for Industry and for FDA Staff | 08/14/2000 | 10/23/2020 |
Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices | 05/11/1988 | 10/23/2020 |
Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices | 02/17/1993 | 10/23/2020 |
Guidance Document for Testing Biodegradable Polymer Implant Devices - Draft Guidance | 04/19/1996 | 10/23/2020 |
Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo) | 05/16/1989 | 10/19/2020 |
Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo) | 07/11/1995 | 10/19/2020 |
Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27) | 10/16/1980 | 06/01/2020 |
Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff | 12/29/2015 | 03/20/2020 |
Transfer of a Premarket Notification (510(k)) Clearance - Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff | 12/22/2014 | 03/20/2020 |
Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices - Guidance for Industry | 07/27/2000 | 09/26/2019 |
Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions - Guidance for Industry and FDA Staff | 01/22/2009 | 09/13/2019 |
In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency - Guidance for Industry and FDA Staff | 11/06/2009 | 09/13/2019 |
Frequently Asked Questions on the New 510(k) Paradigm - Guidance for Industry | 10/22/1998 | 09/12/2019 |
Medical Device Reporting - Remedial Action Exemption; Guidance for FDA and Industry | 09/26/2001 | 06/20/2019 |
Medical Device Reporting - Alternative Summary Reporting (ASR) Program | 10/19/2000 | 06/20/2019 |
Review Criteria for Assessment of Apha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies | 07/15/1994 | 04/26/2019 |
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions | 04/13/2015 | 12/18/2018 |
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - Guidance for Industry and FDA | 02/25/2003 | 12/12/2018 |
The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff | 08/23/2013 | 10/16/2018 |
Guidance on IDE Policies and Procedures | 01/20/1998 | 09/25/2018 |
Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem | 05/15/1998 | 09/25/2018 |
In Vitro Diagnostic Sodium Test System - Final Guidance for Industry | 06/06/1998 | 09/25/2018 |
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System - Final Guidance for Industry | 06/06/1998 | 09/25/2018 |
In Vitro Diagnostic Glucose Test System - Final Guidance for Industry | 06/06/1998 | 09/25/2018 |
In Vitro Diagnostic Creatinine Test System - Final Guidance for Industry | 07/02/1998 | 09/25/2018 |
In Vitro Diagnostic Urea Nitrogen Test System - Final Guidance for Industry | 07/06/1998 | 09/25/2018 |
In Vitro Diagnostic Chloride Test System - Final Guidance for Industry | 07/06/1998 | 09/25/2018 |
In Vitro Diagnostic Potassium Test System - Final Guidance for Industry | 07/06/1998 | 09/25/2018 |
Retinoscope Guidance - Guidance for Industry | 07/08/1998 | 09/25/2018 |
Guidance Document for Surgical Lamp 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance | 07/13/1998 | 09/25/2018 |
Neonatal and Neonatal Transport Incubators - Premarket Notifications - Guidance for Industry and FDA Reviewers/Staff | 09/18/1998 | 09/25/2018 |
Harmonic Imaging with/without Contrast - Premarket Notification Requirements - Guidance for Industry | 11/16/1998 | 09/25/2018 |
SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols | 11/02/1998 | 09/25/2018 |
Battery Guidelines | 01/01/1994 | 09/25/2018 |
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use - Guidance for Industry | 07/01/2002 | 08/09/2018 |
Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents - Draft Guidance for Industry and FDA Staff | 07/19/2007 | 08/03/2018 |
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA | 03/02/2001 | 05/03/2018 |
Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device - Final Guidance for FDA Reviewers and Industry | 11/30/2000 | 03/08/2018 |
Wireless Medical Telemetry Risks and Recommendations - Guidance for Industry | 09/27/2000 | 03/08/2018 |
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff | 04/22/2015 | 02/20/2018 |
Guidance for Industry: A Suggested Approach to Resolving Least Burdensome Issues | 09/11/2000 | 02/02/2018 |
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA | 11/17/2004 | 02/02/2018 |
MEDWATCH Medical Device Reporting Code Instructions | 04/04/2001 | 11/16/2017 |
Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 29KB) | 10/14/2014 | 02/20/2015 |
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices | 05/17/2013 | 08/03/2017 |
Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices | 12/19/2011 | 06/01/2020 |
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator | 10/17/2011 | 09/15/2014 |
Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device | 07/27/2011 | 07/15/2012 |
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices | 06/15/2011 | 08/03/2017 |
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection | 05/18/2011 | 04/27/2015 |
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing | 05/11/2011 | 08/03/2017 |
Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder | 02/07/2011 | 04/27/2015 |
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) | 01/05/2011 | 08/03/2017 |
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile | 11/29/2010 | 10/05/2016 |
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori | 09/23/2010 | 08/03/2017 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media | 04/05/2010 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications | 01/20/2010 | 04/27/2015 |
Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007 | 10/08/2009 | 05/13/2013 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander | 12/22/2008 | 04/27/2015 |
The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program | 01/08/2008 | 11/19/2012 |
Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices | 08/08/2007 | 07/08/2014 |
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material | 06/07/2007 | 08/03/2017 |
In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff | 05/01/2007 | 08/03/2017 |
Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices | 02/27/2007 | 10/05/2016 |
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device | 10/31/2006 | 04/27/2015 |
Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems | 10/24/2006 | 01/31/2011 |
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 | 10/19/2006 | 06/01/2020 |
Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures | 11/10/2005 | 08/03/2017 |
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices | 11/08/2005 | 04/27/2015 |
(Withdrawn): Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators | 10/06/2005 | 04/27/2011 |
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use | 11/30/2004 | 04/28/2017 |
Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove | 04/13/2004 | 08/03/2017 |
Consumer-Directed Broadcast Advertising of Restricted Devices | 02/10/2004 | 09/28/2012 |
Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff | 12/02/2003 | 04/27/2015 |
510(k) Submissions for Coagulation Instruments | 06/19/2003 | 06/01/2020 |
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA | 03/07/2002 | 10/05/2016 |
Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices - October 26, 2001 (#D01-01) | 10/26/2001 | 08/12/2016 |
Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA | 08/22/2001 | 09/28/2011 |
Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff | 07/18/2001 | 04/02/2012 |
Implementation of the Biomaterials Access Assurance Act of 1998 | 04/02/2001 | 10/05/2016 |
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff | 02/09/2001 | 03/02/2012 |
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF - 45KB) | 12/21/1999 | 10/05/2016 |
Intraocular Lens Draft Guidance for Industry and for FDA Reviewers | 10/14/1999 | 11/04/2016 |
Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff | 06/24/1999 | 04/02/2012 |
Guidance for FDA Staff: Civil Money Penalty Policy | 06/08/1999 | 09/27/2012 |
Regulation of Medical Devices: Background Information for International Officials | 04/14/1999 | 09/24/2013 |
Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators | 02/22/1999 | 06/01/2020 |
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only) | 10/10/1997 | 04/27/2015 |
Notice to Manufacturers of Bone Mineral Densitometers | 09/25/1997 | 06/01/2020 |
Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document | 09/05/1997 | 04/02/2012 |
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) (PDF - 28KB) | 07/28/1997 | 08/03/2017 |
Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology | 02/28/1997 | 04/27/2015 |
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems | 02/07/1997 | 04/27/2015 |
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions | 01/01/1997 | 12/06/2013 |
Review Criteria For Assessment Of Rheumatoid Factor (Rf) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (Eia), Enzyme Linked Immunosorbent Assay (Elisa), Particle Agglutination Tests, And Laser And Rate Nephelometry | 02/21/1997 | 08/03/2017 |
Reviewers Guidance Checklist For Intramedullary Rods | 02/21/1997 | 08/03/2017 |
Electrocardiograph (ECG) Electrode (PDF - 28KB) | 02/11/1997 | 08/03/2017 |
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators | 02/01/1997 | 08/03/2017 |
Guidance for Submitting Reclassification Petition (PDF - 28KB) | 01/01/1997 | 08/03/2017 |
PMA Review Statistical Checklist (PDF - 28KB) | 01/01/1997 | 08/03/2017 |
Do It By Design - An Introduction to Human Factors in Medical Devices | 12/01/1996 | 10/05/2016 |
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) | 11/06/1996 | 08/03/2017 |
Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs (PDF - 28KB) | 10/30/1996 | 08/03/2017 |
Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications (PDF - 45KB) | 10/26/1996 | 10/05/2016 |
Electromagnetic Compatibility - A Letter to Industry | 09/18/1996 | 07/11/2016 |
Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests (PDF - 28KB) | 09/06/1996 | 08/03/2017 |
Letter to Manufacturers of Falloposcopes (PDF - 45KB) | 09/05/1996 | 10/05/2016 |
Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF - 45KB) | 09/01/1996 | 10/05/2016 |
Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF - 45KB) | 08/23/1996 | 10/05/2016 |
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) | 08/09/1996 | 08/03/2017 |
MDR Guidance Document No. 1 - IOL - E1996004 | 08/06/1996 | 10/05/2016 |
Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) | 07/15/1996 | 08/03/2017 |
Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document | 05/22/1996 | 04/27/2015 |
Medical Device Reporting: An Overview (PDF - 45KB) | 04/01/1996 | 10/05/2016 |
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 (PDF - 28KB) | 03/14/1996 | 08/03/2017 |
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery | 02/20/1996 | 06/02/2020 |
Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) | 02/15/1996 | 08/03/2017 |
Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices | 01/01/1996 | 10/05/2016 |
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) | 09/01/1995 | 06/01/2020 |
Labeling of Laser Products (Laser Notice 45) (PDF - 28KB) | 08/15/1995 | 08/03/2017 |
Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 42KB) | 07/01/1995 | 04/27/2015 |
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes | 07/26/1995 | 08/03/2017 |
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths | 07/26/1995 | 08/03/2017 |
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables | 07/26/1995 | 08/03/2017 |
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems | 07/26/1995 | 08/03/2017 |
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment | 07/26/1995 | 08/03/2017 |
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators | 07/26/1995 | 08/03/2017 |
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory and Home Use | 07/12/1995 | 06/01/2020 |
Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB) | 06/13/1995 | 10/17/2010 |
Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance | 09/26/1994 | 06/01/2020 |
Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF - 42KB) | 03/16/1994 | 04/27/2015 |
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF - 45KB) | 02/28/1994 | 06/13/2014 |
Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) | 01/31/1994 | 06/01/2020 |
Draft 510(K) Submission Requirements for Peak Flow Meters (PDF - 42KB) | 01/13/1994 | 04/27/2015 |
Guideline for the Manufacture of In Vitro Diagnostic Products (PDF - 30KB) | 01/10/1994 | 05/08/2013 |
Draft Emergency Resuscitator Guidance (PDF - 42KB) | 04/14/1993 | 04/27/2015 |
Draft Guidance for Preparation of PMA Applications for Testicular Prostheses | 03/16/1993 | 04/27/2015 |
Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices (PDF Only) (PDF - 42KB) | 09/01/1992 | 04/27/2015 |
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents | 08/01/1992 | 06/01/2020 |
Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe | 12/30/1991 | 06/01/2020 |
Review Criteria for Assessment of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin In Vitro Diagnostic Devices | 09/29/1991 | 06/01/2020 |
Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF - 42KB) | 09/26/1991 | 04/27/2015 |
Review Criteria for Blood Culture Systems | 08/12/1991 | 06/01/2020 |
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers | 07/15/1991 | 06/01/2020 |
Consolidated Review of Submissions for Lasers and Accessories #G90-1 (Blue Book Memo) | 10/18/1990 | 06/01/2020 |
Assignment of Review Documents #I90-2 (blue book memo) | 08/24/1990 | 01/06/2012 |
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases | 05/31/1990 | 06/01/2020 |
Reviewer Guidance for Automatic X-Ray Film Processor 510(k) | 02/01/1990 | 06/01/2020 |
Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions | 10/05/1988 | 04/27/2015 |
Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB) | 10/23/1987 | 06/12/2011 |
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) (PDF - 28KB) | 10/01/1987 | 08/03/2017 |
COMPARISON CHART: 1996 QUALITY System Regulation Versus 1978 GOOD Manufacturing Practices Regulation Versus ANSIIISOIASQC Q9001-1994 AND ISO/DIS 13485:1996 (PDF Version) (PDF - 26KB) | 01/01/1996 | 12/03/2013 |
Importation for Investigation And Evaluation (Laser Notice 38) (PDF - 28KB) | 05/22/1987 | 08/03/2017 |
Industry Representatives on Scientific Panel (PDF - 28KB) | 03/23/1987 | 08/03/2017 |
ODE Executive Secretary Guidance Manual G87-3 | 08/07/1987 | 08/03/2017 |
Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) | 04/18/1986 | 10/05/2016 |
Low Power Laser Exemption (Laser Notice 36) (PDF - 28KB) | 08/23/1985 | 08/03/2017 |
Reporting of New Model Numbers to Existing Model Families | 06/14/1983 | 06/01/2020 |
Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices (PDF - 28KB) | 11/22/1977 | 08/03/2017 |
Emission Delay - Remote Interlock Connector (Laser Notice 21) | 11/11/1977 | 06/01/2020 |
Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode (PDF - 28KB) | 03/08/1977 | 08/03/2017 |
Optional Interlocks - Labeling (Laser Notice 17) | 03/02/1977 | 06/01/2020 |
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF - 45KB) | 12/08/1976 | 10/05/2016 |
Guidelines for Evaluation of Non-Drug IUDs | 09/26/1976 | 10/05/2016 |
Interlock Design (Laser Notice 12) | 09/09/1976 | 06/01/2020 |
Emission Indicator - Visibility (Laser Notice 10) | 08/31/1976 | 06/01/2020 |
Components and Repair (Laser Notice 7) | 06/23/1976 | 06/01/2020 |
Emission Indicators - Brightness (Laser Notice 6) | 06/22/1976 | 06/01/2020 |
Tabulated Values of Accessible Emission Limits for Laser Products | 03/01/1976 | 06/01/2020 |
Emission Indicators on Energy Source (Laser Notice 3) | 01/21/1975 | 06/01/2020 |
Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4) | 01/21/1975 | 06/01/2020 |
Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21-CFR 1002.10 | 03/01/1973 | 06/01/2020 |
New FDA Recommendations and Results of Contact Lens Study (7 day letter) | 05/30/1989 | 08/03/2020 |
Heated Humidifier Review Guidance | 08/01/1993 | 08/03/2020 |
Guidance for Peak Flow Meters for Over-the-Counter Sale | 06/23/1992 | 08/03/2020 |
Important Information About Rophae Intraocular Lenses | 08/20/1992 | 08/03/2020 |
Dental Handpiece Sterilization (Dear Doctor Letter) | 09/28/1992 | 08/03/2020 |
Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification | 01/14/1998 | 08/03/2020 |
Ophthalmoscope Guidance - (Direct and Indirect) - Guidance for Industry | 07/07/1998 | 08/03/2020 |
Dental Impression Materials Premarket Notification - Guidance for Industry and FDA Staff | 08/16/1998 | 08/03/2020 |
Dental Cements - Premarket Notification - Guidance for Industry and FDA Staff | 08/17/1998 | 08/03/2020 |
Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application | 12/31/1988 | 08/03/2020 |
Coronary and Cerebrovascular Guidewire Guidance | 01/01/1995 | 08/03/2020 |
Electrocardiograph (ECG) Surface Electrode Tester | 02/11/1997 | 08/03/2020 |
Electrocardiograph (ECG) Lead Switching Adapter | 02/11/1997 | 08/03/2020 |
Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter - Final Guidance for Industry and FDA Reviewers | 11/07/2000 | 08/03/2020 |
Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) | 05/01/1978 | 08/03/2020 |
Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) | 02/13/1989 | 08/03/2020 |
Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases | 04/04/1990 | 08/03/2020 |
Letter - Condom Manufacturers and Distributors | 04/05/1994 | 08/03/2020 |
Guidance For The Content Of Premarket Notifications For Urodynamic/Uroflowmetry Systems | 07/28/1994 | 08/03/2020 |
Guidance on the Content of Premarket Notification [510(K)] Submissions for Protective Restraints | 11/30/1995 | 08/03/2020 |
CPG Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) | 02/26/1991 | 10/07/2002 |
CPG Sec. 315.200 Status of Dental Supplies Such as Denture Cleaners Adhesives, Cushions, and Repair Materials as a Device or Cosmetic | 04/26/1976 | 08/07/2002 |
CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices |