The Office of the Chief Medical Officer (OCMO) is sharing the following lists of guidance documents for public review and input:
- Guidance documents we intend to publish in calendar year 2025.
- Guidance documents we are developing and intend to publish in calendar years 2026-2027 as resources permit.
These lists include topics that currently have no guidance associated with them, topics for which updated guidance may be helpful, and topics for which OCMO has already issued draft guidances that may be finalized following review of public comments. We currently intend to develop guidance documents on these topics; however, OCMO is neither bound by these lists of topics, nor required to issue every guidance document on the lists. Several factors may impact our ability to issue a guidance, including, for example, new administration priorities, emerging public health issues, or other extenuating circumstances. We may also issue guidance documents on topics not on these lists.
You may submit comments on the guidance topics in these lists at www.regulations.gov at Docket FDA-2024-N-5427.
Although you may submit comments at any time, OCMO appreciates comments on the guidance topics in these lists by March 14, 2025. Comments submitted by this date will allow OCMO to make any necessary adjustments to its guidance development plans in a more timely manner.
| OCMO Lead Office | Guidance Topic | Type | Category |
|---|---|---|---|
| Office of Clinical Policy | Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Research under 21 CFR 50.22† | New Draft Guidance | Clinical Trials |
| Office of Combination Products | Unique Device Identifier (UDI) Requirements for Combination Products | New Draft Guidance | Combination Products |
| Office of Combination Products | Choosing the Appropriate Center for a Master File Submission | New Draft Guidance | Medical Products |
| Office of Combination Products | Labeling for Infusion Pumps that Deliver Subcutaneous Insulin | New Draft Guidance | Medical Products |
| Office of Combination Products | How to Prepare a Pre-Request for Designation (Pre-RFD) | Final Guidance | Medical Products |
| Office of Orphan Products Development | Formatting and Assembling Requests for Orphan Drug Designation | New Draft Guidance | Rare Diseases |
| Office of Orphan Products Development | Overview of the Orphan Drug Designation Program | New Draft Guidance | Rare Diseases |
† Note: This guidance is being developed in collaboration with the HHS Office for Human Research Protections.
| OCMO Lead Office | Guidance Topic | Type | Category |
|---|---|---|---|
| Office of Clinical Policy | Key Information and Facilitating Understanding in Informed Consent† | Final Guidance | Clinical Trials |
| Office of Clinical Policy | Payment and Reimbursement to Research Participants | Revision to Existing Final Guidance | Clinical Trials |
| Office of Combination Products | Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products | Final Guidance | Combination Products |
| Office of Combination Products | Submissions for Postapproval Modifications to a Combination Product | Revision to Existing Draft Guidance | Combination Products |
| Office of Combination Products | Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors | Final Guidance | Combination Products |
| Office of Pediatric Therapeutics | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | Final Guidance | Pediatric Product Development |
| Office of Pediatric Therapeutics | Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections | Final Guidance | Pediatric Product Development |
† Note: This guidance is being developed in collaboration with the HHS Office for Human Research Protections.
