The Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP) ended March 31, 2021.
If you would like to obtain information about the regulatory status of a human cell, tissue, or cellular or tissue-based product (HCT/P) including, for example, whether an HCT/P meets the criteria in 21 CFR.1271.10(a) for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 you may submit a request to one of the following:
- FDA’s Tissue Reference Group (TRG) which provides product manufacturers and sponsors with an informal process through which they may obtain an Agency recommendation regarding the application of the criteria in 21 CFR 1271.10(a) to their HCT/P for a given indication for use.
- The Request for Designation (RFD) process which may be used to obtain a formal Agency decision regarding the regulatory identity or classification of an HCT/P from FDA’s Office of Combination Products (OCP). Information on how to write an RFD is posted on the agency’s website.
- The Pre-RFD process, which is used to obtain preliminary feedback from OCP on the classification of an HCT/P. Information on this process may be found on the agency’s website.