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[DOI] [PMC free article] [PubMed] [Google Scholar] 73.Kokoeva MV, Yin H, Flier JS

Devices that are part of the Breakthrough Devices Program, have received FDA marketing authorization for the indication covered by the Breakthrough Devices designation, and meet the other criteria in the regulation can be approved through the quarterly process and announced through that process (81 FR 79655)

Critical Issues: By simultaneously curing cutaneous and other tissue wounds (colocutaneous, gastrocutaneous, esophagocutaneous, duodenocutaneous, vesicovaginal, and rectovaginal) in rats, the potency of BPC 157 is evident

Second and relatedly, the list of procedure codes with which device category codes may be reported is not unalterable

doi: 10.1016/S0140-6736(08)61525-1

Do not apply strong actives to freshly treated skin unless your provider says it is appropriate