CDRH medical device sponsor warning letter.(Regulatory Update)(Center for Devices and Radiological Health)

FDA's Center for Devices and Radiological Health (CDRH) issued an Oct. 4, 2004, warning letter to a medical device company in Centerville, Mass. The letter was issued to the company as a sponsor and a monitor of medical device investigations, and resulted from an FDA bioresearch monitoring inspection conducted at the company between April 5-15, 2004. According to FDA, the inspection report revealed several violations of FDA regulations, which are excerpted from the warning letter below.

Failure to establish written procedures for monitoring the investigation (21 CFR 812.25); Failure to ensure, proper monitoring of the investigational study (21 CFR 812.40).

 
   Pursuant to 21 CFR 812.25, a sponsor is 
   responsible for providing within the investigational 
   plan written procedures for monitoring 
   the investigation. Pursuant to 21 CFR 812.40, a …