Regulatory Compliance
Regulatory Compliance
FDA Inspection – December 2023
FDA Tissue Reference Group (TRG) Recommendation Letter – August 2020 (Confidential)
“To be regulated solely under section 361, an HCT/P must satisfy all four criteria at 21 CFR 1271.10(a)1. The TRG reviewed and discussed the materials you submitted. Based on the description of the processing steps you provide, Procenta®, when intended to serve as a cover, to offer protection from the surrounding environment, or to retain fluid, would meet the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.”