| Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff |
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| 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 |
