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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Withdrawn Guidance

This page lists CDRH guidance documents that have been withdrawn and no longer represent FDA's current thinking.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Withdrawn CDRH Guidance Documents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
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Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff 12/29/2015 03/20/2020
Transfer of a Premarket Notification (510(k)) Clearance - Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff 12/22/2014 03/20/2020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The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff 08/23/2013 10/16/2018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
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