| 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| FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories |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| In Vitro Diagnostic Multivariate Index Assays - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff |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| Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories |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 |
