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Withdrawn Guidance

This page lists CDRH guidance documents that have been withdrawn and no longer represent FDA's current thinking.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Withdrawn CDRH Guidance Documents

TitleIssue
Date
Withdrawl
Date
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use - Guidance for Industry07/01/0208/09/18
Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents - Draft Guidance for Industry and FDA Staff07/19/0708/03/18
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA03/02/0105/03/18
Deciding When To Submit A 510(k) For A Change To An Existing Wireless Telemetry Medical Device - Final Guidance for FDA Reviewers and Industry11/30/0003/08/18
Wireless Medical Telemetry Risks and Recommendations - Guidance for Industry09/27/0003/08/18
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff04/22/1502/20/18
Guidance for Industry: A Suggested Approach to Resolving Least Burdensome Issues09/11/0002/02/18
Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA11/17/0402/02/18
MEDWATCH Medical Device Reporting Code Instructions04/04/0111/16/17
Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 29KB)10/14/1402/20/15
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices05/17/1308/03/17
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens03/19/1206/13/17
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator10/17/1109/15/14
Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device07/27/1107/15/12
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant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 Devices06/15/1108/03/17
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection05/18/1104/27/15
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 Testing05/11/1108/03/17
Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder02/07/1104/27/15
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)01/05/1108/03/17
Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile11/29/1010/05/16
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori09/23/1008/03/17
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media04/05/1004/27/15
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications01/20/1004/27/15
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 200710/08/0905/13/13
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander12/22/0804/27/15
The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program01/08/0811/19/12
Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices08/08/0707/08/14
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material06/07/0708/03/17
In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff05/01/0708/03/17
Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices02/27/0710/05/16
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device10/31/0604/27/15
Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems10/24/0601/31/11
Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures11/10/0508/03/17
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices11/08/0504/27/15
(Withdrawn): Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators10/06/0504/27/11
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use11/30/0404/28/17
Guidance for Industry and FDA Staff: Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove04/13/0408/03/17
Consumer-Directed Broadcast Advertising of Restricted Devices02/10/0409/28/12
Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff12/02/0304/27/15
Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA03/07/0210/05/16
Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices - October 26, 2001 (#D01-01)10/26/0108/12/16
Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA08/22/0109/28/11
Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff07/18/0104/02/12
Implementation of the Biomaterials Access Assurance Act of 199804/02/0110/05/16
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff02/09/0103/02/12
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF - 45KB)12/21/9910/05/16
Intraocular Lens Draft Guidance for Industry and for FDA Reviewers10/14/9911/04/16
Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff06/24/9904/02/12
Guidance for FDA Staff: Civil Money Penalty Policy06/08/9909/27/12
Regulation of Medical Devices: Background Information for International Officials04/14/9909/24/13
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only)10/10/9704/27/15
Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document09/05/9704/02/12
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) (PDF - 28KB)07/28/9708/03/17
Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology02/28/9704/27/15
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems02/07/9704/27/15
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions01/01/9712/06/13
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 Nephelometry02/21/9708/03/17
Reviewers Guidance Checklist For Intramedullary Rods02/21/9708/03/17
Electrocardiograph (ECG) Electrode (PDF - 28KB)02/11/9708/03/17
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators02/01/9708/03/17
Guidance for Submitting Reclassification Petition (PDF - 28KB)01/01/9708/03/17
PMA Review Statistical Checklist (PDF - 28KB)01/01/9708/03/17
Do It By Design - An Introduction to Human Factors in Medical Devices12/01/9610/05/16
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)11/06/9608/03/17
Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs (PDF - 28KB)10/30/9608/03/17
Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications (PDF - 45KB)10/26/9610/05/16
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA09/19/9608/03/17
Electromagnetic Compatibility - A Letter to Industry09/18/9607/11/16
Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests (PDF - 28KB)09/06/9608/03/17
Letter to Manufacturers of Falloposcopes (PDF - 45KB)09/05/9610/05/16
Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF - 45KB)09/01/9610/05/16
Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF - 45KB)08/23/9610/05/16
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3)08/09/9608/03/17
MDR Guidance Document No. 1 - IOL - E199600408/06/9610/05/16
Continued Access to Investigational Devices During PMA Preparation and Review July 15, 1996 (Blue Book Memo) (D96-1)07/15/9608/03/17
Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document05/22/9604/27/15
Medical Device Reporting: An Overview (PDF - 45KB)04/01/9610/05/16
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 (PDF - 28KB)03/14/9608/03/17
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)02/15/9608/03/17
Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices01/01/9610/05/16
Labeling of Laser Products (Laser Notice 45) (PDF - 28KB)08/15/9508/03/17
Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 42KB)07/01/9504/27/15
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes07/26/9508/03/17
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Immersion Hydrobaths07/26/9508/03/17
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables07/26/9508/03/17
Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems07/26/9508/03/17
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment07/26/9508/03/17
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators07/26/9508/03/17
Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB)06/13/9510/17/10
Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF - 42KB)03/16/9404/27/15
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF - 45KB)02/28/9406/13/14
Draft 510(K) Submission Requirements for Peak Flow Meters (PDF - 42KB)01/13/9404/27/15
Guideline for the Manufacture of In Vitro Diagnostic Products (PDF - 30KB)01/10/9405/08/13
Draft Emergency Resuscitator Guidance (PDF - 42KB)04/14/9304/27/15
Draft Guidance for Preparation of PMA Applications for Testicular Prostheses03/16/9304/27/15
Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices (PDF Only) (PDF - 42KB)09/01/9204/27/15
Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF - 42KB)09/26/9104/27/15
Assignment of Review Documents #I90-2 (blue book memo)08/24/9001/06/12
Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions10/05/8804/27/15
Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB)10/23/8706/12/11
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) (PDF - 28KB)10/01/8708/03/17
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)05/22/8708/03/17
Industry Representatives on Scientific Panel (PDF - 28KB)03/23/8708/03/17
ODE Executive Secretary Guidance Manual G87-308/07/8708/03/17
Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo)04/18/8610/05/16
Low Power Laser Exemption (Laser Notice 36) (PDF - 28KB)08/23/8508/03/17
Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices (PDF - 28KB)11/22/7708/03/17
Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode (PDF - 28KB)03/08/7708/03/17
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF - 45KB)12/08/7610/05/16
Guidelines for Evaluation of Non-Drug IUDs09/26/7610/05/16

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