| Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) | 06/24/2007 | 12/31/2024 |
| The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13: Guidance for Industry, MQSA Inspectors and FDA Staff | 11/16/2010 | 09/10/2024 |
| The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12 | 02/02/2007 | 09/10/2024 |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final | 11/05/2001 | 09/10/2024 |
| Mammography Facility Surveys, Mammography Equipment Evaluations, and Medical Physicist Qualification Requirements under MQSA | 09/13/2005 | 09/10/2024 |
| Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter | 11/08/2004 | 08/12/2024 |
| Manufacturers And Initial Distributors Of Sharps Containers And Destroyers Used By Health Care Professionals | 02/03/1994 | 08/12/2024 |
| Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation | 01/09/2004 | 08/12/2024 |
| Premarket Notification - Consistency of Reviews #K89-1 (Blue Book Memo) | 02/01/1989 | 05/31/2024 |
| FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories | 10/03/2014 | 05/06/2024 |
| In Vitro Diagnostic Multivariate Index Assays - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff | 05/26/2007 | 05/06/2024 |
| Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories | 10/03/2014 | 05/06/2024 |
| A Guide For The Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | 03/01/1996 | 02/21/2023 |
| Format for Traditional and Abbreviated 510(k)s | 09/12/2019 | 10/02/2023 |
| Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies | 03/27/2008 | 09/27/2023 |
| Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies - Companion Document | 03/27/2008 | 09/27/2023 |
| Implantable Pacemaker Testing Guidance | 01/01/1990 | 09/12/2023 |
| Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff | 07/15/2003 | 09/12/2023 |
| Infectious 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 | 04/05/2023 |
| Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug Administration Staff | 12/12/2016 | 10/17/2022 |
| Effects 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 | 07/07/2022 |
| CPG 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 | 11/12/2002 |
| CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps | 10/01/1980 | 06/20/2002 |
| CPG Sec. 355.100 Cellutron Machine | 05/31/1990 | 03/10/2005 |
| CPG Sec. 370.200 RIA Analysis of Hair to Detect the Prescence of Drugs of Abuse | 05/31/1990 | 01/05/2004 |
| CPG Sec. 305.100 - Acupuncture Devices and Accessories | 06/15/1976 | 01/24/2000 |
| CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h) | 03/01/1995 | 04/22/2022 |
| CPG Sec. 310.200 Sphygmomanometers - Rx Legend | 09/24/1987 | 04/22/2022 |
| CPG Sec. 393.100 Enforcement Policy for Certain Laser Light Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11) | 03/01/2005 | 04/22/2022 |
| CPG Sec. 398.425 Override of Positive Beam Limitation - 21 CFR 1020.31(g)(5) | 03/01/2005 | 04/22/2022 |
| CPG 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 | 04/22/2022 |
| CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements | 12/06/2005 | 04/22/2022 |
| Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and FDA Staff | 08/14/2015 | 11/15/2021 |
| Hospital 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 | 09/30/2021 |
| Recommendations 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 | 06/30/2021 |
| Enforcement 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 | 06/30/2021 |
| Manufacturer'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 | 05/27/2021 |
| Inspection 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 | 05/27/2021 |
| Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices | 12/01/1983 | 10/23/2020 |
| Preamendments Class III Strategy | 04/19/1994 | 10/23/2020 |
| Alternative to Certain Prescription Device Labeling Requirements - Guidance for Industry | 01/21/2000 | 10/23/2020 |
| Reprocessing and Reuse of Single-Use Devices - Guidance for Industry and FDA Reviewers | 02/08/2000 | 10/23/2020 |
| Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals - Guidance for Industry and for FDA Staff | 08/14/2000 | 10/23/2020 |
| Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices | 05/11/1988 | 10/23/2020 |
| Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament Devices | 02/17/1993 | 10/23/2020 |
| Guidance Document for Testing Biodegradable Polymer Implant Devices - Draft Guidance | 04/19/1996 | 10/23/2020 |
| Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo) | 05/16/1989 | 10/19/2020 |
| Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo) | 07/11/1995 | 10/19/2020 |
| 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 |
| CPG Sec. 390.500 Definition of "High-Voltage Vacuum Switch" - 21 CFR 1002.61(a)(3) and (b)(2) | 10/01/1980 | 12/07/2010 |
| 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 |
| CPG 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 | 10/07/2002 |
| CPG Sec. 315.200 Status of Dental Supplies Such as Denture Cleaners Adhesives, Cushions, and Repair Materials as a Device or Cosmetic | 04/26/1976 | 08/07/2002 |
| CPG Sec. 300.200 - Reconditioners/Rebuilders of Medical Devices | 12/29/1987 | 01/24/2000 |
| CPG Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 1050.10(c)(1)(ii) | 03/01/1995 | 02/21/2023 |
| Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems | 12/01/1985 | 02/21/2023 |
| A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use | 03/01/1996 | 02/21/2023 |
| Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | 09/01/1995 | 02/21/2023 |
| Guidance 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 | 02/21/2023 |
| Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens | 10/20/2006 | 02/21/2023 |
| Low Power Laser Reporting Exemption (Laser Notice 41) | 08/09/1988 | 02/21/2023 |
| Exemption from Reporting under 21 CFR 1002 | 02/24/1986 | 02/21/2023 |
| Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only) | 08/01/1996 | 02/21/2023 |
