Medical Devices

Withdrawn Guidance

This page lists CDRH guidance documents that have been withdrawn. These documents only contain the withdrawal date. The original content is no longer available.

Withdrawn CDRH Guidance Documents

TitleOrganizationDoc #Date
(Withdrawn) Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 29KB) OIR/DIH/HB CBER 1787 10/14/14
(Withdrawn) Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the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 Specimens OIR 1788 03/19/12
(Withdrawn) Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator ODE/DCD 1769 10/17/11
(Withdrawn) Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device CDRH CBER 1793 07/27/11
(Withdrawn) Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection OIVD/DMD 1677 05/18/11
(Withdrawn) Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder OSEL ODE/DAGID 1704 02/07/11
(Withdrawn) Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of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 OIVD/DMD 1715 11/29/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended ODE/DRARD/ULDB 1670 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning ODE/DRARD/ULDB 1580 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning ODE/DRARD/ULDB 1579 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation ODE/DRARD/ULDB 1578 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes ODE/DRARD/ULDB 1576 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation ODE/DRARD/ULDB 1577 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes ODE/DRARD/ULDB 1575 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief ODE/DRARD/ULDB 1574 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief ODE/DRARD/ULDB 1573 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode ODE/DRARD/ULDB 1572 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media ODE/DRARD/ULDB 1571 04/05/10
(Withdrawn) Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications ODE/DCD/CSPDB 1607 01/20/10
(Withdrawn) 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 OC/DRMO/RPSB 1657 10/08/09
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander ODE/DGRND/PRSB 1628 12/22/08
(Withdrawn) The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program OC/DBM 1602 01/08/08
(Withdrawn) Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices OIVD/DIHD 772 08/08/07
(Withdrawn) Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices OC 1227 02/27/07
(Withdrawn) Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device ODE/DGRND 1558 10/31/06
(Withdrawn) Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems OIVD/DCTD 1603 10/24/06
(Withdrawn) Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tinnitus Masker Devices ODE/DOED/ENTB 1555 11/08/05
(Withdrawn): Draft Guidance for Industry and FDA Staff - Functional Indications for Implantable Cardioverter Defibrillators ODE OC 1304 10/06/05
(Withdrawn) Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CBER CDRH 4444 11/30/04
(Withdrawn) Consumer-Directed Broadcast Advertising of Restricted Devices OC 1513 02/10/04
(Withdrawn) Premarket Submissions and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff OIVD/DCTD 152 12/02/03
(Withdrawn) Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/02
(Withdrawn) Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices - October 26, 2001 (#D01-01) ODE 10/26/01
(Withdrawn) Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA OIVD/DIHD 800 08/22/01
(Withdrawn) Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff ODE 1341 07/18/01
(Withdrawn) Implementation of the Biomaterials Access Assurance Act of 1998 OC 1324 04/02/01
(Withdrawn) CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff OCE/DHC 1323 02/09/01
(Withdrawn) Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing (PDF - 45KB) OIVD/DCTD 1359 12/21/99
(Withdrawn) Intraocular Lens Draft Guidance for Industry and for FDA Reviewers ODE/DOD 834 10/14/99
(Withdrawn) Guidance on Labeling for Laboratory Tests - Draft Guidance for Industry and for FDA Reviewers/Staff OIVD 1352 06/24/99
(Withdrawn) Guidance for FDA Staff: Civil Money Penalty Policy OC 1124 06/08/99
(Withdrawn) Regulation of Medical Devices: Background Information for International Officials OCE/DICE 610 04/14/99
(Withdrawn) Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages - October 10, 1997 (P97-1) (Text Only) ODE 563 10/10/97
(Withdrawn) Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document ODE/DOED/DSDB 7093 09/05/97
(Withdrawn) Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology OIVD/DCTD 604 02/28/97
(Withdrawn) A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems OSEL 952 02/07/97
(Withdrawn) In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions OCE/DICE 471 01/01/97
(Withdrawn) Do It By Design - An Introduction to Human Factors in Medical Devices OCER/DHC 995 12/01/96
(Withdrawn) Carotid Stent - Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications (PDF - 45KB) ODE/DCD/PVDB 974 10/26/96
(Withdrawn) Electromagnetic Compatibility - A Letter to Industry OC/DE3 1087 09/18/96
(Withdrawn) Letter to Manufacturers of Falloposcopes (PDF - 45KB) ODE/DRARD/OGDB 1344 09/05/96
(Withdrawn) Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF - 45KB) 09/01/96
(Withdrawn) Shielded Trocars and Needles used for Abdominal Access during Laparoscopy (PDF - 45KB) OC/DE2 1122 08/23/96
(Withdrawn) MDR Guidance Document No. 1 - IOL - E1996004 OSB/DSS 216 08/06/96
(Withdrawn) Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document ODE/DGRND/PRSB 958 05/22/96
(Withdrawn) Medical Device Reporting: An Overview (PDF - 45KB) OSB/DSS 509 04/01/96
(Withdrawn) Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices OSB 476 01/01/96
(Withdrawn) Draft Reviewer Guidance for Ventilators (PDF Only) (PDF - 42KB) ODE/DAGID/ARDB 500 07/01/95
(Withdrawn) Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions (PDF Only) (PDF - 15KB) ODE 639 06/13/95
(Withdrawn) Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF - 42KB) ODE/DAGID/ARDB 996 03/16/94
(Withdrawn) Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)] (PDF - 45KB) OIVD/DMD 862 02/28/94
(Withdrawn) Draft 510(K) Submission Requirements for Peak Flow Meters (PDF - 42KB) ODE/DAGID/ARDB 999 01/13/94
(Withdrawn) Guideline for the Manufacture of In Vitro Diagnostic Products (PDF - 30KB) OIVD 918 01/10/94
(Withdrawn) Draft Emergency Resuscitator Guidance (PDF - 42KB) ODE/DAGID/ARDB 985 04/14/93
(Withdrawn) Draft Guidance for Preparation of PMA Applications for Testicular Prostheses ODE/DRARD/ULDB 809 03/16/93
(Withdrawn) Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices (PDF Only) (PDF - 42KB) OIVD/DIHD 785 09/01/92
(Withdrawn) Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies (PDF - 42KB) OIVD/DIHD 475 09/26/91
(Withdrawn) Assignment of Review Documents #I90-2 (blue book memo) ODE 366 08/24/90
(Withdrawn) Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions OIVD 272 10/05/88
(Withdrawn) Limulus Amebocute Lysate; Reduction of Samples for Testing (PDF - 44KB) ODE 178 10/23/87
(Withdrawn) 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) OCE/DICE 133
(Withdrawn) Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo) ODE 306 04/18/86
(Withdrawn) Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 15) (PDF - 45KB) OIR/DRH 12/08/76
(Withdrawn) Guidelines for Evaluation of Non-Drug IUDs ODE/DRARD/OGDB 641 09/26/76

Page Last Updated: 04/28/2017
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