Medical Device Manufacturers
Guide to Inspections of Medical Device Manufacturers
December 1997
4
GUIDE TO INSPECTIONS OF
MEDICAL DEVICE MANUFACTURERS
TABLE OF CONTENTS
ATTACHMENTS
Page Title | Page Number |
A - Medical Device Industry Initiative | 25 |
B - Temporary Enforcement Moratorium | 29 |
C - FOI and Design Controls | 31 |
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.
Return to: Page Top | Inspection Start