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 2026.
- Guidance documents we are developing and intend to publish in calendar years 2027-2028 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 revised or 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 priorities, emerging public health issues, or other extenuating circumstances. We may also issue guidance documents on topics that are not included 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 June 8, 2026. 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 | Category |
|---|---|---|
| Office of Combination Products | Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products | Combination Products |
| Office of Combination Products | Current Good Manufacturing Practice Requirements for Combination Products | Combination Products |
| Office of Combination Products | Labeling for Infusion Pumps that Deliver Subcutaneous Insulin | Medical Products |
| Office of Public Health Preparedness and Response | Emergency Use Authorization of Medical Products and Related Authorities | Medical Products |
Anticipated Guidances—Calendar Years 2026-2027
| OCMO Lead Office | Guidance Topic | Category |
|---|---|---|
| Office of Clinical Policy | Key Information and Facilitating Understanding in Informed Consent† | Clinical Trials |
| Office of Clinical Policy | Payment and Reimbursement to Research Participants | Clinical Trials |
| Office of Clinical Policy | Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Research under 21 CFR 50.22† | Clinical Trials |
| Office of Combination Products | Unique Device Identifier (UDI) Requirements for Combination Products | Combination Products |
| Office of Combination Products | Submissions for Postapproval Modifications to a Combination Product | Combination Products |
| Office of Combination Products | Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors | Combination Products |
| Office of Combination Products | Cross-Center Master Files: Where to Submit | Medical Products |
| Office of Pediatric Therapeutics | Ethical Considerations for Clinical Investigations of Medical Products Involving Children | 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 | Pediatric Product Development |
| Office of Orphan Products Development | Formatting and Assembling Requests for Orphan Drug Designation | Rare Diseases |
| Office of Orphan Products Development | Overview of the Orphan Drug Designation Program | Rare Diseases |
† Note: This guidance is being developed in collaboration with the HHS Office for Human Research Protections.
Additional Resources
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Content current as of:
04/09/2026
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