Inspections, Compliance, Enforcement, and Criminal Investigations
|Guide to Inspections of Medical Device Manufacturers||December 1997|
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:
- This reference is intended to be used in conjunction with the:
- Compliance Program Guidance Manuals for Medical Device Manufacturers (CP 7382.830 (GMP) and 7382.830A (Sterilization)),
- Investigations Operations Manual (IOM),
- Code of Federal Regulations, Title 21 (21 CFR) Part 820 Quality System Regulation,
- Compliance Policy Guides (CPG) for devices (beginning with the numbers 7124 and 7133), and
- Guideline on General Principles of Process Validation, FDA, May 1987.
Other references include:
- the Safe Medical Devices Act (SMDA) of 1990 and the Medical Device Amendments of 1992,
- Medical Device Quality Systems Manual: A Small Entity Compliance Guide,
- The FDA Worldwide Quality System Requirements Guidebook for Medical Devices, and;
- other device specific guidance documents prepared by CDRH for the medical device industry.
These additional guidances are posted to the CDRH Internet World Wide Web Home Page at http://www.fda.gov/cdrh