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for which CDRH is interested in receiving external feedback about whether these guidances should be revised or withdrawn.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

On this page:

• A-list
• B-list
• Retrospective review list for 1984, 1994, 2004, and 2014
• How to comment on these guidance lists or a specific guidance

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Draft Guidance Topics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 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

How to comment on these guidance lists or a specific guidance

CDRH would appreciate comments on any or all the guidance documents on the three lists by December 11, 2023.

Specifically, CDRH is seeking comments on the relative priority of guidance documents on the A-list and B-list, as well as proposed policy or information for the FDA to consider for inclusion in these guidances. CDRH also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.

For the retrospective review list, CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn to help inform the retrospective review of existing final guidances. If a recommendation is made to withdraw or request a modification to an existing guidance document, CDRH requests that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.

CDRH also welcomes any additional feedback for improving the guidance program and the quality of guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that stakeholder needs are met.

You may submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with docket number FDA-2012-N-1021 for "Instructions for Submitting Comments on the CDRH Fiscal Year 2024 Proposed Guidance Development."

Submit electronic comments to www.regulations.gov. Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the  document entitled "Instructions for Submitting Comments on the CDRH Fiscal Year 2023 Proposed Guidance Development" located on www.regulations.gov under docket number FDA-2012-N-1021.

Metrics for FY 2023 A-list and B-list Publication

Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2023 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2023, CDRH published 12 of 18 guidances on the FY 2023 list (10 from the A-list, 2 from the B-list).  

Metrics for the Finalization of Draft Guidance Documents

The percentage of draft guidances issued FY 2016 onward that CDRH has finalized, withdrawn, reopened the comment period, or issued new draft guidance within 3 years or within 5 years of the comment period close is as follows:

Fiscal Year	Action taken within 3 years	Action taken within 5 years
FY 2016	23 of 29 (79%)	25 of 29 (86%)
FY 2017	6 of 6 (100%)	6 of 6 (100%)
FY 2018	22 of 24 (92%)	(96%)
FY 2019	23 of 25 (92%)	5 years not yet reached
FY2020	9 of 10 (90%)	10 of 10 (100%)

In addition, in FY 2023, 4 draft guidances issued prior to October 1, 2017, remain for which no action has been taken yet, and CDRH has been continuing to work towards taking an action on these remaining draft guidances.  Looking forward, in FY 2024, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2018.

Applicability of Previously Issued Final Guidance

In FY 2023, CDRH received comments regarding guidances issued in 2013, 2003, and 1993 and the revision of several guidance documents are being considered and pursued as resources permit. Two guidances that no longer reflect the FDA’s current thinking were withdrawn.