Device Inspections Guide

accreditation activities agency amended applicable appropriate approved assessment CDRH complaint compliance program components conducted contract sterilizer corrective and preventive definition deleted design and development design control requirements design history design input requirements design output design review design validation device manufacturers district ensure equipment establish and maintain evaluation facility FDA agrees FDA believes FDA disagrees FDA's Federal Food Federal Register final rule finished device firm guidance document harmonization identified implementation individual(s intended labeling Louis Kaufman maintain procedures manufacturer shall establish manufacturing materials Manufacturing Practice master record medical device Medical Device Directive methods necessary ORTHOSIS packaging and labeling performed personnel PMA Supplement Premarket preventive action proposed QS/GMP QSIT quality system regulation quality system requirements Radiological Health records request response revised specifications submit Subpart suppliers testing TRANSMITTAL verification and validation Warning Letter WEAC