Guideline

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Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA
Internet:	http://www.fda.gov/cdrh/comp/guidance/7382.845.html
Origin/Publisher:	FDA http://www.fda.gov/cdrh/comp/guidance/7382.845.html
Content:	This compliance program provides guidance to FDA field and center staffs for the inspections and administrative/enforcement activities related to the Quality System/Good Manufacturing Practices (QS/GMP) regulation (21 CFR Part 820), the Medical Device Reporting (MDR) regulation (21 CFR Part 803), the Medical Device Tracking regulation (21 CFR Part 821), the Corrections and Removals regulation (21 CFR Part 806), and the Registration and Listing regulation (21 CFR Part 807).
Status:	Guidance
Document Type:	Guidance