Banner
HomeCompliance Update → The FDA Inspection and Enforcement Process: A Guide for HCT/P Manufacturers and Providers 

The FDA Inspection and Enforcement Process: A Guide for HCT/P Manufacturers and Providers  Print E-mail
Written by Matthew Fischer, Florida Healthcare Law Firm   
Tuesday, 30 January 2018 00:00

In November 2017, the U.S. Food and Drug Administration (FDA) issued new guidance regarding its current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271(a) and the agency's view on the same surgical procedure exception under 21 CFR 1271.15(b).  Additionally, the FDA issued a notice to all interested stakeholders that the agency intends to initiate increased discretionary enforcement over the next 36 months for HCT/P businesses.  Based on the agency's latest position, it is important for HCT/P manufacturers and providers to understand the inspection process and be prepared to respond accordingly in this heightened regulatory environment.

Last Updated on Wednesday, 31 January 2018 10:28
 


Banner
Website design, development, and hosting provided by
Netphiles