place with no pre-market review or approval. If they are regulated
solely under PHSsec. 361 and 21 C.F.R. Part 1271. To meet this
criteria: I) the cells have ... companies to bring products to market
simply by claiming that they fall under the PHSsec. 361 and 21
C.F.R. Part 1271 and then simply wait ... without the typical pre-market review process. The company has been marketing Grafix
under PHSsec. 361 and 21 C.F.R. Part 1271. As we understand under this regulatory framework, company