Qsr 21 Cfr Part 820 For Medical Devices

eCFR :: 21 CFR Part 820 -- Quality System Regulation

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

Medical Devices; Current Good Manufacturing Practice …

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820

§ 820.80 - Receiving, in-process, and finished device acceptance. § 820.86 - Acceptance status. Subpart I - Nonconforming Product § 820.90 - …