Request that the FDA amend 21 C.F.R. § 1271.10(a) to provide that stem cell products shall be regulated solely under section 361 of the Public Health Service Act and 21 C.F.R. Part 1271 (i.e., as 361 HCTPs) provided that the stem cell products and their production facilities comply with the current good manufacturing practices and certain production facility | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-6021

Request that the FDA amend 21 C.F.R. § 1271.10(a) to provide that stem cell products shall be regulated solely under section 361 of the Public Health Service Act and 21 C.F.R. Part 1271 (i.e., as 361 HCTPs) provided that the stem cell products and their production facilities comply with the current good manufacturing practices and certain production facility

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensNov 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CBER to Orrick, Herrington & Sutcliffe LLP and BakerHostetler	May 6, 2026	--

Comment Statistics

Total Comments

Keywords

CBER

Citizen Petition

amend 21 C.F.R. S 1271.10(a) to provide

that stem cell products shall be regulated

solely under section 361 of the Public Health

Service Act and 21 C.F.R. Part 1271

(i.e., as 361 HCT/Ps) provided that the

stem cell products and their production

Data from Regulations.gov