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
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents - Guidance for Industry and Food and Drug Administration Staff	11/14/22
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff	10/07/22
Procedures for Handling Post-Approval Studies Imposed by PMA Order - Guidance for Industry and Food and Drug Administration Staff	10/07/22
Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff	09/28/22
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions	09/28/22
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff	09/28/22
Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff	09/28/22
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff	09/28/22
Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff	09/28/22
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff	09/27/22
Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff	09/22/22
Policy for Monkeypox Tests to Address the Public Health Emergency - Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff	09/07/22
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff	08/17/22
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Guidance for Industry and Food and Drug Administration Staff	08/17/22
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices - Guidance for Industry and Food and Drug Administration Staff	07/25/22
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff	06/16/22
Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff	06/06/22
Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus - Guidance for Industry and Food and Drug Administration Staff	05/06/22
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff	05/04/22
Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	04/13/22
Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	04/13/22
Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	04/11/22
Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	04/11/22
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders - Guidance for Mammography Facilities and Food and Drug Administration Staff	03/02/22
Center for Devices and Radiological Health (CDRH) Appeals Processes - Guidance for Industry and Food and Drug Administration Staff	03/02/22
Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) - Guidance for Industry and Food and Drug Administration Staff	12/27/21
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff	12/23/21
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff	11/15/21
Surgical Staplers and Staples for Internal Use - Labeling Recommendations - Guidance for Industry and Food and Drug Administration Staff	10/08/21
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff	10/05/21
De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff	10/05/21
User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff	10/05/21
Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff	10/05/21
Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff	09/15/21
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Guidance for Industry and Food and Drug Administration Staff	07/07/21
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages - Guidance for Industry and Food and Drug Administration Staff	05/21/21
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations - Guidance for Industry and Food and Drug Administration Staff	05/20/21
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and Food and Drug Administration Staff	05/20/21
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff	05/20/21
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests - Guidance for Test Developers and Food and Drug Administration Staff	02/22/21
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff	01/28/21
Safer Technologies Program for Medical Devices - Guidance for Industry and Food and Drug Administration Staff	01/06/21
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff	01/06/21
Mouse Embryo Assay for Assisted Reproduction Technology Devices - Guidance for Industry and Food and Drug Administration Staff	01/05/21
Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff	12/30/20
Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	12/11/20
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	12/11/20
Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff	12/11/20
Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency - Guidance for Mammography Facilities, State MQSA Contract Partners, FDA-Approved MQSA Accreditation Bodies, and Food and Drug Administration Staff	12/04/20
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
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
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