AccessMyLibrary provides FREE access to millions of articles from top publications available through your library.
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 …