# Federal Register #2026-21713

FDA public comment request on product jurisdiction and combination-product information collection

**Buyer:** Department of Health and Human Services / Food and Drug Administration
**Posted:** October 23, 2026
**Respond By:** December 23, 2026
**Identifier:** 2026-21713

The FDA is seeking public input on an information collection about product jurisdiction and combination products, not purchasing goods or services.
- Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA).
- Scope: Information collection supporting FDA product-classification and jurisdiction determinations under 21 CFR Parts 3 and 4.
  - Covers Requests for Designation (RFDs), Pre-RFD submissions, and Combination Product Agreement Meeting (CPAM) requests.
- Respondents and estimated burden: 149 respondents annually—52 RFD requests, 94 Pre-RFD submissions, and 3 CPAM requests—with an estimated 3,579 total annual burden hours.
  - Estimated response time: 24 hours per RFD or Pre-RFD submission and 25 hours per CPAM request.
- No OEMs, vendors, products, or quantities for purchase are identified. This is a regulatory comment request, not a procurement opportunity.

### Description

The FDA is soliciting public comments on an information collection concerning product jurisdiction and combination product regulations under 21 CFR Parts 3 and 4. The collection supports FDA product classification and jurisdiction determinations, including Requests for Designation (RFDs), Pre-RFD submissions, and Combination Product Agreement Meeting requests. Respondents are sponsors of medical products, including combination products; FDA estimates 149 respondents annually. Comments are due December 22, 2026.

[View original listing](https://www.federalregister.gov/documents/2026/10/23/2026-21713/agency-information-collection-activities-proposed-collection-comment-request-product-jurisdiction)