CDRH Proposed Guidances for Fiscal Year 2024(FY2024)
The lists on this page include guidance documents the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish this fiscal year (FY2024), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback about whether these guidances should be revised or withdrawn.
These lists are:
The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2024.
The B-list: A list of device guidance documents the FDA intends to publish as resources permit during FY2024.
Retrospective review list: A list of final guidance documents issued in 1984, 1994, 2004, and 2014
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2024
Final Guidance Topics
Remanufacturing of Medical Devices
Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
Marketing Submission Recommendations for A Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Draft Guidance Topics
Artificial Intelligence/Machine Learning (AI/ML)-enabled Device Software Functions: Lifecycle Management Considerations and Premarket Submission Recommendations
Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture
Select Updates for Premarket Cybersecurity Guidance: Cyber Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)
Pulse Oximeters – Assessing Clinical and Scientific Evidence (revision)
Predetermined Change Control Plans for Medical Devices
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)
Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564
Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564
Factors FDA Intends to Consider in Issuing an Enforcement Policy for Unapproved Tests Under a Declaration Under Section 564
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance
Chemical Analysis for Biocompatibility Assessment of Medical Devices
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision)
The Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
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) Program (revision)
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program (revision)
Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (revision)
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2024
Final Guidance Topics
Computer Software Assurance for Production and Quality System Software
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
Draft Guidance Topics
3D Printing Medical Devices at the Point of Care
Retrospective Review List of Guidances for 1984, 1994, 2004, and 2014
1984 Final Guidances
None
1994 Final Guidances
Manufacturers And Initial Distributors Of Sharps Containers And Destroyers Used By Health Care Professionals
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement
Guidance for the Content of Premarket Notifications for Urine Drainage Bags
Points to Consider for Cervical Cytology Devices
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments
Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology
2004 Final Guidances
Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation
Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions
Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff
Guidance for Industry and FDA Staff: Spinal System 510(k)s
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff
Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff
Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff
2014 Final Guidances
Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff
Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff
Medical Device Tracking: Guidance for Industry and FDA Staff
Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff
Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff
In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff
Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff
FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff
Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff
Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff
Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff
Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration Staff
Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff
