Guide to Inspections of Medical Device Manufacturers |
December 1997 |
1 |
|
The "Guide to Inspections of Medical Device Manufacturers" is a consolidation of information previously provided in the May 4, 1995 Compliance Program (CP), Inspections of Medical Device Manufacturers, CP 7382.830, Attachments A. B and E only. This guide was prepared by the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health (CDRH). The new Quality System Regulation (F.R. vol. 61, No. 195, October 7, 1996) became effective on June 1, 1997. To implement the revised regulation CP 7382.830 has been rewritten and information relative to how to inspect a medical device manufacturer has been removed. The Compliance Program still contains information on when to do a directed inspection, the definitions of comprehensive and directed inspections, and other device specific policy requirements. This reference is intended to be used in conjunction with the:
These additional guidances are posted to the CDRH Internet World Wide Web
Home Page at http://www.fda.gov/cdrh
|
Note: this document is reference materials for investigators and other FDA personnel. This Document does not bind FDA, and does not confer any rights, privileges, benifits, or immunities for or on any personnel.