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                Guidance Documents (Medical Devices and Radiation-Emitting Products)

Guidance Documents (Medical Devices and Radiation-Emitting Products)

                        Cross-Center Final Guidance
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          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Withdrawn or Expired GuidanceGuidance Documents (Medical Devices and Radiation-Emitting Products) Withdrawn or Expired Guidance
  
  	
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Withdrawn CDRH Guidance Documents
	Expired CDRH Guidance DocumentsWithdrawn CDRH Guidance Documents

This table lists CDRH guidance documents that have been withdrawn and no longer represent FDA's current thinking. These documents are presented for historical purposes only.

Title
			Issue
			Date
			Withdrawal
			DateFormat for Traditional and Abbreviated 510(k)s
			09/12/2019
			10/02/2023Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies
			03/27/2008
			09/27/2023Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies - Companion Document
			03/27/2008
			09/27/2023Implantable Pacemaker Testing Guidance
			01/01/1990
			09/12/2023Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff
			07/15/2003
			09/12/2023Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers - Draft Guidance for Industry and Food and Drug Administration Staff
			05/13/2016
			04/05/2023Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug Administration Staff
			12/12/2016
			10/17/2022Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff
			12/22/2020
			07/07/2022CPG Sec. 398.475 Minimum X-ray Field Size for Spot-Film Operation of Fluoroscopic Systems with Fixed SID and Without Stepless Adjustment of the Field Size
			10/01/1980
			11/12/2002CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps
			10/01/1980
			06/20/2002CPG Sec. 355.100 Cellutron Machine
			05/31/1990
			03/10/2005CPG Sec. 370.200 RIA Analysis of Hair to Detect the Prescence of Drugs of Abuse
			05/31/1990
			01/05/2004CPG Sec. 305.100 - Acupuncture Devices and Accessories
			06/15/1976
			01/24/2000CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h)
			03/01/1995
			04/22/2022CPG Sec. 310.200 Sphygmomanometers - Rx Legend
			09/24/1987
			04/22/2022CPG Sec. 393.100 Enforcement Policy for Certain Laser Light Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11)
			03/01/2005
			04/22/2022CPG Sec. 398.425 Override of Positive Beam Limitation - 21 CFR 1020.31(g)(5)
			03/01/2005
			04/22/2022CPG Sec. 394.500 Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation during Design Development
			07/29/2004
			04/22/2022CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements
			12/06/2005
			04/22/2022Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and FDA Staff
			08/14/2015
			11/15/2021Hospital Reprocessors: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use - Guidance for Industry and Food and Drug Administration Staff
			04/24/2001
			09/30/2021Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
			05/26/2020
			06/30/2021Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Healthcare Organizations, Healthcare Personnel, and Food and Drug Administration Staff
			11/25/2020
			06/30/2021Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) - Guidance for Industry, FDA Staff, and FDA
			03/02/2009
			05/27/2021Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria - Guidance for Industry, FDA Staff, and Third Parties
			08/06/2009
			05/27/2021Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices
			12/01/1983
			10/23/2020Preamendments Class III Strategy
			04/19/1994
			10/23/2020Alternative to Certain Prescription Device Labeling Requirements - Guidance for Industry
			01/21/2000
			10/23/2020Reprocessing and Reuse of Single-Use Devices - Guidance for Industry and FDA Reviewers
			02/08/2000
			10/23/2020Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals - Guidance for Industry and for FDA Staff
			08/14/2000
			10/23/2020Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices
			05/11/1988
			10/23/2020Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices
			02/17/1993
			10/23/2020Guidance Document for Testing Biodegradable Polymer Implant Devices - Draft Guidance
			04/19/1996
			10/23/2020Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo)
			05/16/1989
			10/19/2020Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo)
			07/11/1995
			10/19/2020Laser Diodes Used in Fiber Optics Communication Systems (Laser Notice 27)
			10/16/1980
			06/01/2020Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses - Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff
			12/29/2015
			03/20/2020Transfer of a Premarket Notification (510(k)) Clearance - Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff
			12/22/2014
			03/20/2020Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices - Guidance for Industry
			07/27/2000
			09/26/2019Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions - Guidance for Industry and FDA Staff
			01/22/2009
			09/13/2019In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency - Guidance for Industry and FDA Staff
			11/06/2009
			09/13/2019Frequently Asked Questions on the New 510(k) Paradigm - Guidance for Industry
			10/22/1998
			09/12/2019Medical Device Reporting - Remedial Action Exemption; Guidance for FDA and Industry
			09/26/2001
			06/20/2019Medical Device Reporting - Alternative Summary Reporting (ASR) Program
			10/19/2000
			06/20/2019Review Criteria for Assessment of Apha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies
			07/15/1994
			04/26/2019Expedited 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
			12/18/2018Assessing 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
			12/12/2018The 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
			10/16/2018Guidance on IDE Policies and Procedures
			01/20/1998
			09/25/2018Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem
			05/15/1998
			09/25/2018In Vitro Diagnostic Sodium Test System - Final Guidance for Industry
			06/06/1998
			09/25/2018In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System - Final Guidance for Industry
			06/06/1998
			09/25/2018In Vitro Diagnostic Glucose Test System - Final Guidance for Industry
			06/06/1998
			09/25/2018In Vitro Diagnostic Creatinine Test System - Final Guidance for Industry
			07/02/1998
			09/25/2018In Vitro Diagnostic Urea Nitrogen Test System - Final Guidance for Industry
			07/06/1998
			09/25/2018In Vitro Diagnostic Chloride Test System - Final Guidance for Industry
			07/06/1998
			09/25/2018In Vitro Diagnostic Potassium Test System - Final Guidance for Industry
			07/06/1998
			09/25/2018Retinoscope Guidance - Guidance for Industry
			07/08/1998
			09/25/2018Guidance Document for Surgical Lamp 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance
			07/13/1998
			09/25/2018Neonatal and Neonatal Transport Incubators - Premarket Notifications - Guidance for Industry and FDA Reviewers/Staff
			09/18/1998
			09/25/2018Harmonic Imaging with/without Contrast - Premarket Notification Requirements - Guidance for Industry
			11/16/1998
			09/25/2018SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols
			11/02/1998
			09/25/2018Battery Guidelines
			01/01/1994
			09/25/2018Cardiac Ablation Catheters Generic Arrhythmia Indications for Use - Guidance for Industry
			07/01/2002
			08/09/2018Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents - Draft Guidance for Industry and FDA Staff
			07/19/2007
			08/03/2018Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA
			03/02/2001
			05/03/2018Deciding 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
			03/08/2018Wireless Medical Telemetry Risks and Recommendations - Guidance for Industry
			09/27/2000
			03/08/2018Acceptance 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
			02/20/2018Guidance for Industry: A Suggested Approach to Resolving Least Burdensome Issues
			09/11/2000
			02/02/2018Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA
			11/17/2004
			02/02/2018MEDWATCH Medical Device Reporting Code Instructions
			04/04/2001
			11/16/2017Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 29KB)
			10/14/2014
			02/20/2015Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices
			05/17/2013
			08/03/2017Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices
			12/19/2011
			06/01/2020Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator
			10/17/2011
			09/15/2014Guidance 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
			07/15/2012Draft 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
			08/03/2017Draft 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
			04/27/2015Draft 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
			08/03/2017Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
			02/07/2011
			04/27/2015Draft 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
			08/03/2017Draft 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
			10/05/2016Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
			09/23/2010
			08/03/2017Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes
			04/05/2010
			04/27/2015Draft 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
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media
			04/05/2010
			04/27/2015Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
			01/20/2010
			04/27/2015Guidance 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
			05/13/2013Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander
			12/22/2008
			04/27/2015The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program
			01/08/2008
			11/19/2012Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices
			08/08/2007
			07/08/2014Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material
			06/07/2007
			08/03/2017In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff
			05/01/2007
			08/03/2017Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices
			02/27/2007
			10/05/2016Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device
			10/31/2006
			04/27/2015Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
			10/24/2006
			01/31/2011Provision 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
			06/01/2020Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures
			11/10/2005
			08/03/2017Draft 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
			04/27/2011Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
			11/30/2004
			04/28/2017Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove
			04/13/2004
			08/03/2017Consumer-Directed Broadcast Advertising of Restricted Devices
			02/10/2004
			09/28/2012Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff
			12/02/2003
			04/27/2015510(k) Submissions for Coagulation Instruments
			06/19/2003
			06/01/2020Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
			03/07/2002
			10/05/2016Procedures 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
			08/12/2016Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA
			08/22/2001
			09/28/2011Availability 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
			04/02/2012Implementation of the Biomaterials Access Assurance Act of 1998
			04/02/2001
			10/05/2016CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
			02/09/2001
			03/02/2012Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF - 45KB)
			12/21/1999
			10/05/2016Intraocular Lens Draft Guidance for Industry and for FDA Reviewers
			10/14/1999
			11/04/2016Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff
			06/24/1999
			04/02/2012Guidance for FDA Staff: Civil Money Penalty Policy
			06/08/1999
			09/27/2012Regulation of Medical Devices: Background Information for International Officials
			04/14/1999
			09/24/2013Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
			02/22/1999
			06/01/2020Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only)
			10/10/1997
			04/27/2015Notice to Manufacturers of Bone Mineral Densitometers
			09/25/1997
			06/01/2020Discussion 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
			04/02/2012Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944)(PDF - 28KB)
			07/28/1997
			08/03/2017Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology
			02/28/1997
			04/27/2015A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems
			02/07/1997
			04/27/2015In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
			01/01/1997
			12/06/2013Review 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
			08/03/2017Reviewers Guidance Checklist For Intramedullary Rods
			02/21/1997
			08/03/2017Electrocardiograph (ECG) Electrode (PDF - 28KB)
			02/11/1997
			08/03/2017Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
			02/01/1997
			08/03/2017Guidance for Submitting Reclassification Petition (PDF - 28KB)
			01/01/1997
			08/03/2017PMA Review Statistical Checklist (PDF - 28KB)
			01/01/1997
			08/03/2017Do It By Design - An Introduction to Human Factors in Medical Devices
			12/01/1996
			10/05/2016Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
			11/06/1996
			08/03/2017Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs (PDF - 28KB)
			10/30/1996
			08/03/2017Carotid 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
			10/05/2016Electromagnetic Compatibility - A Letter to Industry
			09/18/1996
			07/11/2016Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests (PDF - 28KB)
			09/06/1996
			08/03/2017Letter to Manufacturers of Falloposcopes (PDF - 45KB)
			09/05/1996
			10/05/2016Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF - 45KB)
			09/01/1996
			10/05/2016Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF - 45KB)
			08/23/1996
			10/05/2016Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3)
			08/09/1996
			08/03/2017MDR Guidance Document No. 1 - IOL - E1996004
			08/06/1996
			10/05/2016Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1)
			07/15/1996
			08/03/2017Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document
			05/22/1996
			04/27/2015Medical Device Reporting: An Overview (PDF - 45KB)
			04/01/1996
			10/05/2016Points 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
			08/03/2017Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery
			02/20/1996
			06/02/2020Review 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
			08/03/2017Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices
			01/01/1996
			10/05/2016Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)
			09/01/1995
			06/01/2020Labeling of Laser Products (Laser Notice 45) (PDF - 28KB)
			08/15/1995
			08/03/2017Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 42KB)
			07/01/1995
			04/27/2015Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes
			07/26/1995
			08/03/2017Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths
			07/26/1995
			08/03/2017Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables
			07/26/1995
			08/03/2017Guidance 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
			08/03/2017Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment
			07/26/1995
			08/03/2017Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators
			07/26/1995
			08/03/2017Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory and Home Use
			07/12/1995
			06/01/2020Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB)
			06/13/1995
			10/17/2010Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
			09/26/1994
			06/01/2020Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF - 42KB)
			03/16/1994
			04/27/2015Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF - 45KB)
			02/28/1994
			06/13/2014Review 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
			06/01/2020Draft 510(K) Submission Requirements for Peak Flow Meters (PDF - 42KB)
			01/13/1994
			04/27/2015Guideline for the Manufacture of In Vitro Diagnostic Products (PDF - 30KB)
			01/10/1994
			05/08/2013Draft Emergency Resuscitator Guidance (PDF - 42KB)
			04/14/1993
			04/27/2015Draft Guidance for Preparation of PMA Applications for Testicular Prostheses
			03/16/1993
			04/27/2015Draft 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
			04/27/2015Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents
			08/01/1992
			06/01/2020Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe
			12/30/1991
			06/01/2020Review Criteria for Assessment of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin In Vitro Diagnostic Devices
			09/29/1991
			06/01/2020Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF - 42KB)
			09/26/1991
			04/27/2015Review Criteria for Blood Culture Systems
			08/12/1991
			06/01/2020Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers
			07/15/1991
			06/01/2020Consolidated Review of Submissions for Lasers and Accessories #G90-1 (Blue Book Memo)
			10/18/1990
			06/01/2020Assignment of Review Documents #I90-2 (blue book memo)
			08/24/1990
			01/06/2012Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases
			05/31/1990
			06/01/2020CPG Sec. 390.500 Definition of "High-Voltage Vacuum Switch" - 21 CFR 1002.61(a)(3) and (b)(2)
			10/01/1980
			12/07/2010Reviewer Guidance for Automatic X-Ray Film Processor 510(k)
			02/01/1990
			06/01/2020Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions
			10/05/1988
			04/27/2015Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB)
			10/23/1987
			06/12/2011Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) (PDF - 28KB)
			10/01/1987
			08/03/2017COMPARISON 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
			12/03/2013Importation for Investigation And Evaluation (Laser Notice 38) (PDF - 28KB)
			05/22/1987
			08/03/2017Industry Representatives on Scientific Panel (PDF - 28KB)
			03/23/1987
			08/03/2017ODE Executive Secretary Guidance Manual G87-3
			08/07/1987
			08/03/2017Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo)
			04/18/1986
			10/05/2016Low Power Laser Exemption (Laser Notice 36) (PDF - 28KB)
			08/23/1985
			08/03/2017Reporting of New Model Numbers to Existing Model Families
			06/14/1983
			06/01/2020Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices (PDF - 28KB)
			11/22/1977
			08/03/2017Emission Delay - Remote Interlock Connector (Laser Notice 21)
			11/11/1977
			06/01/2020Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode (PDF - 28KB)
			03/08/1977
			08/03/2017Optional Interlocks - Labeling (Laser Notice 17)
			03/02/1977
			06/01/2020Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF - 45KB)
			12/08/1976
			10/05/2016Guidelines for Evaluation of Non-Drug IUDs
			09/26/1976
			10/05/2016Interlock Design (Laser Notice 12)
			09/09/1976
			06/01/2020Emission Indicator - Visibility (Laser Notice 10)
			08/31/1976
			06/01/2020Components and Repair (Laser Notice 7)
			06/23/1976
			06/01/2020Emission Indicators - Brightness (Laser Notice 6)
			06/22/1976
			06/01/2020Tabulated Values of Accessible Emission Limits for Laser Products
			03/01/1976
			06/01/2020Emission Indicators on Energy Source (Laser Notice 3)
			01/21/1975
			06/01/2020Protective Eyewear - Visibility of Emission Indicator (Laser Notice 4)
			01/21/1975
			06/01/2020Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21-CFR 1002.10
			03/01/1973
			06/01/2020New FDA Recommendations and Results of Contact Lens Study (7 day letter)
			05/30/1989
			08/03/2020Heated Humidifier Review Guidance
			08/01/1993
			08/03/2020Guidance for Peak Flow Meters for Over-the-Counter Sale
			06/23/1992
			08/03/2020Important Information About Rophae Intraocular Lenses
			08/20/1992
			08/03/2020Dental Handpiece Sterilization (Dear Doctor Letter)
			09/28/1992
			08/03/2020Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification
			01/14/1998
			08/03/2020Ophthalmoscope Guidance - (Direct and Indirect) - Guidance for Industry
			07/07/1998
			08/03/2020Dental Impression Materials Premarket Notification - Guidance for Industry and FDA Staff
			08/16/1998
			08/03/2020Dental Cements - Premarket Notification - Guidance for Industry and FDA Staff
			08/17/1998
			08/03/2020Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application
			12/31/1988
			08/03/2020Coronary and Cerebrovascular Guidewire Guidance
			01/01/1995
			08/03/2020Electrocardiograph (ECG) Surface Electrode Tester
			02/11/1997
			08/03/2020Electrocardiograph (ECG) Lead Switching Adapter
			02/11/1997
			08/03/2020Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter - Final Guidance for Industry and FDA Reviewers
			11/07/2000
			08/03/2020Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)
			05/01/1978
			08/03/2020Letter - Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)
			02/13/1989
			08/03/2020Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases
			04/04/1990
			08/03/2020Letter - Condom Manufacturers and Distributors
			04/05/1994
			08/03/2020Guidance For The Content Of Premarket Notifications For Urodynamic/Uroflowmetry Systems
			07/28/1994
			08/03/2020Guidance on the Content of Premarket Notification [510(K)] Submissions for Protective Restraints
			11/30/1995
			08/03/2020CPG 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
			10/07/2002CPG Sec. 315.200 Status of Dental Supplies Such as Denture Cleaners Adhesives, Cushions, and Repair Materials as a Device or Cosmetic
			04/26/1976
			08/07/2002CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices
			12/29/1987
			01/24/2000CPG Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii)
			03/01/1995
			02/21/2023Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems
			12/01/1985
			02/21/2023A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use
			03/01/1996
			02/21/2023Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps
			09/01/1995
			02/21/2023Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes
			10/20/2006
			02/21/2023Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens
			10/20/2006
			02/21/2023Low Power Laser Reporting Exemption (Laser Notice 41)
			08/09/1988
			02/21/2023Exemption from Reporting under 21 CFR 1002
			02/24/1986
			02/21/2023Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only)
			08/01/1996
			02/21/2023

Expired CDRH Guidance Documents

This table lists CDRH guidance documents that have expired as outlined in the guidance, such as due to the expiration of a public health emergency declaration or declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizing emergency use of a device, and no longer represent FDA's current thinking. These documents are presented for historical purposes only.

Title
			Issue
			Date
			Expiration
			DateCybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff
			03/30/2023
			10/01/2023Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages - Guidance for Industry and Food and Drug Administration Staff
			05/21/2021
			09/24/2023Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID–19 Public Health Emergency (Revised)
			11/25/2020
			05/12/2023Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID–19 Public Health Emergency
			12/04/2020
			05/12/2023Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 Public Health Emergency
			04/24/2020
			11/07/2023Enforcement Policy for Imaging Systems During the COVID-19 Public Health Emergency
			04/23/2020
			11/07/2023Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency
			04/23/2020
			11/07/2023Enforcement Policy for Telethermographic Systems During the COVID-19 Public Health Emergency
			04/16/2020
			11/07/2023Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency
			04/14/2020
			11/07/2023Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency
			04/06/2020
			11/07/2023Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 Public Health Emergency
			04/06/2020
			11/07/2023Enforcement Policy for Infusion Pumps and Accessories During the COVID-19 Public Health Emergency
			04/05/2020
			11/07/2023Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the COVID-19 Public Health Emergency
			03/13/2023
			11/07/2023Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 Public Health Emergency
			03/30/2020
			11/07/2023Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the COVID-19 Public Health Emergency
			03/29/2020
			11/07/2023Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID-19 Public Health Emergency
			03/22/2020
			11/07/2023Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the COVID-19 Public Health Emergency
			10/13/2020
			11/07/2023Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the COVID-19 Public Health Emergency (Revised)
			01/28/2021
			11/07/2023Enforcement Policy for Viral Transport Media During the COVID-19 Public Health Emergency (Revised)
			11/15/2021
			11/07/2023Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date
			10/28/2020
			02/04/2023

                                                                                  Content current as of:
      11/28/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products)

          
                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents
 
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