Medical Devices

Withdrawn Guidance

This page lists CDRH guidance documents that have been withdrawn and no longer represent FDA's current thinking.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Withdrawn CDRH Guidance Documents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
Withdrawl
Date
The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff 08/23/13 10/16/18
Guidance on IDE Policies and Procedures 01/20/98 09/25/18
Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem 05/15/98 09/25/18
In Vitro Diagnostic Sodium Test System - Final Guidance for Industry 06/06/98 09/25/18
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System - Final Guidance for Industry 06/06/98 09/25/18
In Vitro Diagnostic Glucose Test System - Final Guidance for Industry 06/06/98 09/25/18
In Vitro Diagnostic Creatinine Test System - Final Guidance for Industry 07/02/98 09/25/18
In Vitro Diagnostic Urea Nitrogen Test System - Final Guidance for Industry 07/06/98 09/25/18
In Vitro Diagnostic Chloride Test System - Final Guidance for Industry 07/06/98 09/25/18
In Vitro Diagnostic Potassium Test System - Final Guidance for Industry 07/06/98 09/25/18
Retinoscope Guidance - Guidance for Industry 07/08/98 09/25/18
Guidance Document for Surgical Lamp 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance 07/13/98 09/25/18
Neonatal and Neonatal Transport Incubators - Premarket Notifications - Guidance for Industry and FDA Reviewers/Staff 09/18/98 09/25/18
Harmonic Imaging with/without Contrast - Premarket Notification Requirements - Guidance for Industry 11/16/98 09/25/18
SMDA to FDAMA: Guidance on FDA’s Transition Plan for Existing Postmarket Surveillance Protocols 11/02/98 09/25/18
Battery Guidelines 01/01/94 09/25/18
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use - Guidance for Industry 07/01/02 08/09/18
Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents - Draft Guidance for Industry and FDA Staff 07/19/07 08/03/18
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA 03/02/01 05/03/18
Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device - Final Guidance for FDA Reviewers and Industry 11/30/00 03/08/18
Wireless Medical Telemetry Risks and Recommendations - Guidance for Industry 09/27/00 03/08/18
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff 04/22/15 02/20/18
Guidance for Industry: A Suggested Approach to Resolving Least Burdensome Issues 09/11/00 02/02/18
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA 11/17/04 02/02/18
MEDWATCH Medical Device Reporting Code Instructions 04/04/01 11/16/17
Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 29KB) 10/14/14 02/20/15
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices 05/17/13 08/03/17
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator 10/17/11 09/15/14
Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device 07/27/11 07/15/12
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 06/15/11 08/03/17
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection 05/18/11 04/27/15
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 05/11/11 08/03/17
Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder 02/07/11 04/27/15
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) 01/05/11 08/03/17
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 11/29/10 10/05/16
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori 09/23/10 08/03/17
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media 04/05/10 04/27/15
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications 01/20/10 04/27/15
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 10/08/09 05/13/13
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander 12/22/08 04/27/15
The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program 01/08/08 11/19/12
Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices 08/08/07 07/08/14
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material 06/07/07 08/03/17
In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff 05/01/07 08/03/17
Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices 02/27/07 10/05/16
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device 10/31/06 04/27/15
Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems 10/24/06 01/31/11
Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures 11/10/05 08/03/17
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices 11/08/05 04/27/15
(Withdrawn): Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators 10/06/05 04/27/11
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use 11/30/04 04/28/17
Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove 04/13/04 08/03/17
Consumer-Directed Broadcast Advertising of Restricted Devices 02/10/04 09/28/12
Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff 12/02/03 04/27/15
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA 03/07/02 10/05/16
Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices - October 26, 2001 (#D01-01) 10/26/01 08/12/16
Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA 08/22/01 09/28/11
Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff 07/18/01 04/02/12
Implementation of the Biomaterials Access Assurance Act of 1998 04/02/01 10/05/16
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff 02/09/01 03/02/12
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF - 45KB) 12/21/99 10/05/16
Intraocular Lens Draft Guidance for Industry and for FDA Reviewers 10/14/99 11/04/16
Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff 06/24/99 04/02/12
Guidance for FDA Staff: Civil Money Penalty Policy 06/08/99 09/27/12
Regulation of Medical Devices: Background Information for International Officials 04/14/99 09/24/13
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only) 10/10/97 04/27/15
Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document 09/05/97 04/02/12
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) (PDF - 28KB) 07/28/97 08/03/17
Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology 02/28/97 04/27/15
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems 02/07/97 04/27/15
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions 01/01/97 12/06/13
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 02/21/97 08/03/17
Reviewers Guidance Checklist For Intramedullary Rods 02/21/97 08/03/17
Electrocardiograph (ECG) Electrode (PDF - 28KB) 02/11/97 08/03/17
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators 02/01/97 08/03/17
Guidance for Submitting Reclassification Petition (PDF - 28KB) 01/01/97 08/03/17
PMA Review Statistical Checklist (PDF - 28KB) 01/01/97 08/03/17
Do It By Design - An Introduction to Human Factors in Medical Devices 12/01/96 10/05/16
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) 11/06/96 08/03/17
Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs (PDF - 28KB) 10/30/96 08/03/17
Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications (PDF - 45KB) 10/26/96 10/05/16
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA 09/19/96 08/03/17
Electromagnetic Compatibility - A Letter to Industry 09/18/96 07/11/16
Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests (PDF - 28KB) 09/06/96 08/03/17
Letter to Manufacturers of Falloposcopes (PDF - 45KB) 09/05/96 10/05/16
Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF - 45KB) 09/01/96 10/05/16
Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF - 45KB) 08/23/96 10/05/16
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3) 08/09/96 08/03/17
MDR Guidance Document No. 1 - IOL - E1996004 08/06/96 10/05/16
Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1) 07/15/96 08/03/17
Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document 05/22/96 04/27/15
Medical Device Reporting: An Overview (PDF - 45KB) 04/01/96 10/05/16
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 (PDF - 28KB) 03/14/96 08/03/17
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) 02/15/96 08/03/17
Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices 01/01/96 10/05/16
Labeling of Laser Products (Laser Notice 45) (PDF - 28KB) 08/15/95 08/03/17
Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 42KB) 07/01/95 04/27/15
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes 07/26/95 08/03/17
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths 07/26/95 08/03/17
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables 07/26/95 08/03/17
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems 07/26/95 08/03/17
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment 07/26/95 08/03/17
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators 07/26/95 08/03/17
Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB) 06/13/95 10/17/10
Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF - 42KB) 03/16/94 04/27/15
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF - 45KB) 02/28/94 06/13/14
Draft 510(K) Submission Requirements for Peak Flow Meters (PDF - 42KB) 01/13/94 04/27/15
Guideline for the Manufacture of In Vitro Diagnostic Products (PDF - 30KB) 01/10/94 05/08/13
Draft Emergency Resuscitator Guidance (PDF - 42KB) 04/14/93 04/27/15
Draft Guidance for Preparation of PMA Applications for Testicular Prostheses 03/16/93 04/27/15
Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices (PDF Only) (PDF - 42KB) 09/01/92 04/27/15
Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF - 42KB) 09/26/91 04/27/15
Assignment of Review Documents #I90-2 (blue book memo) 08/24/90 01/06/12
Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions 10/05/88 04/27/15
Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB) 10/23/87 06/12/11
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) (PDF - 28KB) 10/01/87 08/03/17
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)   12/03/13
Importation for Investigation And Evaluation (Laser Notice 38) (PDF - 28KB) 05/22/87 08/03/17
Industry Representatives on Scientific Panel (PDF - 28KB) 03/23/87 08/03/17
ODE Executive Secretary Guidance Manual G87-3 08/07/87 08/03/17
Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) 04/18/86 10/05/16
Low Power Laser Exemption (Laser Notice 36) (PDF - 28KB) 08/23/85 08/03/17
Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices (PDF - 28KB) 11/22/77 08/03/17
Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode (PDF - 28KB) 03/08/77 08/03/17
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF - 45KB) 12/08/76 10/05/16
Guidelines for Evaluation of Non-Drug IUDs 09/26/76 10/05/16

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