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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
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff 01/08/24
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff 11/17/23
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act - Guidance for Industry and Food and Drug Administration Staff 11/17/23
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 11/03/23
Enforcement Policy for Clinical Electronic Thermometers - Guidance for Industry and Food and Drug Administration Staff 11/03/23
Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff 11/02/23
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring - Guidance for Industry and Food and Drug Administration Staff 10/19/23
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff 10/10/23
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff 10/10/23
Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff 10/02/23
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Guidance for Industry and Food and Drug Administration Staff 09/29/23
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff 09/27/23
Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff 09/14/23
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Guidance for Industry and Food and Drug Administration Staff 09/14/23
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 09/08/23
Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff 09/05/23
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff 08/11/23
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff 07/27/23
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff 06/14/23
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff 06/02/23
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Guidance for Industry and Food and Drug Administration Staff 05/26/23
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff 04/14/23
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff 03/28/23
General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff 03/28/23
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff 03/27/23
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) - Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff 03/27/23
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Assembler's Guide to Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff 02/21/23
Surveying, Leveling, and Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff 01/31/23
Policy for Coronavirus Disease-2019 Tests (Revised) - Guidance for Developers and Food and Drug Administration Staff 01/12/23
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) - Guidance for Test Developers and Food and Drug Administration Staff 01/12/23
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
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
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
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
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
 
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