| eCopy Program for Medical Device Submissions | 12/03/2025 |
| Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff | 09/24/2025 |
| Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency - Guidance for Industry and Food and Drug Administration Staff | 09/23/2025 |
| Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff | 08/22/2025 |
| Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - Guidance for Industry and Food and Drug Administration Staff | 08/18/2025 |
| Medical Device User Fee Small Business Qualification and Determination - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments | 07/30/2025 |
| Premarket Approval Application and Humanitarian Device Exemption Modular Review - Guidance for Industry and FDA Staff | 01/13/2025 |
| 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 | 01/07/2025 |
| Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff | 12/17/2024 |
| Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices - Guidance for Industry and Food and Drug Administration Staff | 11/25/2024 |
| Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff | 11/22/2024 |
| 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations | 11/21/2024 |
| Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 10/15/2024 |
| Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 09/30/2024 |
| Dental Cements - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 09/30/2024 |
| Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 09/30/2024 |
| Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 09/30/2024 |
| Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff | 09/30/2024 |
| Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders - Guidance for Mammography Facilities and Food and Drug Administration Staff | 09/10/2024 |
| Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff | 08/26/2024 |
| Electronic Submission Template for Medical Device De Novo Requests - Guidance for Industry and Food and Drug Administration Staff | 08/23/2024 |
| 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 | 08/23/2024 |
| Acceptable Media for Electronic Product User Manuals - Guidance for Industry and FDA Staff | 08/20/2024 |
| Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Guidance for Industry and FDA Staff | 07/11/2024 |
| Laboratory Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory Manufacturers and Food and Drug Administration Staff | 06/25/2024 |
| Remanufacturing of Medical Devices - Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff | 05/10/2024 |
| 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 | 01/08/2024 |
| Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff | 11/17/2023 |
| 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 | 11/03/2023 |
| Enforcement Policy for Clinical Electronic Thermometers - Guidance for Industry and Food and Drug Administration Staff | 11/03/2023 |
| 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 | 11/02/2023 |
| Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring - Guidance for Industry and Food and Drug Administration Staff | 10/19/2023 |
| Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff | 10/10/2023 |
| Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff | 10/10/2023 |
| Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff | 10/02/2023 |
| Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology - Guidance for Industry and Food and Drug Administration Staff | 09/29/2023 |
| Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff | 09/27/2023 |
| Breakthrough Devices Program - Guidance for Industry and Food and Drug Administration Staff | 09/14/2023 |
| Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Guidance for Industry and Food and Drug Administration Staff | 09/14/2023 |
| 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 | 09/08/2023 |
| 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 | 09/05/2023 |
| Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff | 08/11/2023 |
| Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff | 07/27/2023 |
| Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff | 06/14/2023 |
| Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff | 06/02/2023 |
| Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Guidance for Industry and Food and Drug Administration Staff | 05/26/2023 |
| Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff | 04/14/2023 |
| Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff | 03/28/2023 |
| General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff | 03/28/2023 |
| 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 | 03/27/2023 |
| 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 | 03/27/2023 |
| 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 | 02/21/2023 |
| Medical X-Ray Imaging Devices Conformance with IEC Standards - Guidance for Industry and Food and Drug Administration Staff | 02/21/2023 |
| Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff | 02/21/2023 |
| Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff | 02/21/2023 |
| Assembler's Guide to Diagnostic X-Ray Equipment - Guidance for Industry and Food and Drug Administration Staff | 02/21/2023 |
| 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 | 02/21/2023 |
| Surveying, Leveling, and Alignment Laser Products - Guidance for Industry and Food and Drug Administration Staff | 01/31/2023 |
| Policy for Coronavirus Disease-2019 Tests (Revised) - Guidance for Developers and Food and Drug Administration Staff | 01/12/2023 |
| Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised) - Guidance for Test Developers and Food and Drug Administration Staff | 01/12/2023 |
