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Human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  As a result, our statutory authority under section 704(a)(4) of the FD&C Act, under which persons are required to submit certain records or other information to FDA in response to a request from FDA in advance of or in lieu of a drug establishment inspection does not apply to these products.  This means that, currently, FDA can request that establishments submit records voluntarily in advance of or in lieu of an inspection for 361 HCT/Ps but in contrast to drug establishments, FDA cannot require that HCT/P establishments provide such records.  Additionally, FDA currently relies on voluntary participation for remote interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing) of establishments that manufacture 361 HCT/Ps.

The proposed amendment to the regulations at 21 CFR part 1271, subpart F would establish requirements for the submission of records or other information to FDA upon request, in advance of or in lieu of an inspection of establishments that manufacture 361 HCT/Ps and require the participation in a remote interactive evaluation of such establishments, upon request by FDA.