| 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 |
| Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff |
11/15/21 |
| 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 |
| Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff |
12/22/20 |
| 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 |
| 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 |
| 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 |
| 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 |
