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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

Recent Final Medical Device Guidance Documents

This list contains the most recent final medical device guidance documents. For a complete listing, please see the Guidance Documents homepage.

Recent Final Guidance Documents

Title Issued Date
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 11/25/20
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff 11/25/20
Regulatory Considerations for Microneedling Products - Guidance for Industry and Food and Drug Administration Staff 11/10/20
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Guidance for Industry and Food and Drug Administration Staff 11/06/20
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff 10/28/20
Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date - Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff 10/28/20
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff 10/15/20
Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 10/13/20
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use - Guidance for Industry and Food and Drug Administration Staff 09/29/20
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Guidance for Industry and Food and Drug Administration Staff 09/29/20
Breast Implants - Certain Labeling Recommendations to Improve Patient Communication - Guidance for Industry and Food and Drug Administration Staff 09/29/20
Saline, Silicone Gel, and Alternative Breast Implants - Guidance for Industry and FDA Staff 09/29/20
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/25/20
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/25/20
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 09/25/20
Recognition and Withdrawal of Voluntary Consensus Standards - Guidance for Industry and Food and Drug Administration Staff 09/15/20
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff 09/04/20
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff 08/14/20
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff 08/14/20
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff 07/20/20
Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff 07/15/20
Clinical Investigations for Prostate Tissue Ablation Devices - Guidance for Industry and Food and Drug Administration Staff 07/15/20
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff 07/01/20
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers - Guidance for Industry and Food and Drug Administration Staff 06/22/20
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 05/26/20
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff 05/26/20
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 05/21/20
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff 05/04/20
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff 05/04/20
eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff 04/27/20
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff 04/24/20
Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/23/20
Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/23/20
Nonbinding Feedback After Certain FDA Inspections of Device Establishments - Guidance for Industry and Food and Drug Administration Staff 04/22/20
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/16/20
Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/14/20
Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/06/20
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/06/20
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/05/20
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/04/20
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/30/20
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/29/20
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff 03/27/20
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/22/20
510(k) Third Party Review Program - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations 03/12/20
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff 03/09/20
Bone Anchors - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff 03/02/20
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Guidance for Industry and Food and Drug Administration Staff 02/26/20
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff 02/26/20
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff 12/20/19
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and Food and Drug Administration Staff 12/16/19
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Guidance for Industry and Food and Drug Administration Staff 10/10/19
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Guidance for Industry and Food and Drug Administration Staff 10/10/19
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff 09/27/19
Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff="/node/381052">Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff  
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 04/04/20
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff 04/02/20
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/30/20
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/29/20
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff 03/27/20
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 03/22/20
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff 03/16/20
510(k) Third Party Review Program - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations 03/12/20
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff 03/09/20
Bone Anchors - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff 03/02/20
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Guidance for Industry and Food and Drug Administration Staff 02/26/20
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff 02/26/20
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff 12/20/19
eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff 12/16/19
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and Food and Drug Administration Staff 12/16/19
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff 12/16/19
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Guidance for Industry and Food and Drug Administration Staff 10/10/19
Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Guidance for Industry and Food and Drug Administration Staff 10/10/19
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff 09/27/19
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