Guideline

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Quality System Information for Certain Premarket Application Reviews, Guidance for Industry
Internet:	http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070899.pdf
Origin/Publisher:	FDA http://www.fda.gov/cdrh/comp/guidance/1140.pdf
Content:	This document discusses information required by the Quality System (QS) regulation (21 CFR part 820) that applicants should include in their premarket approval applications (PMA) and product development protocols (PDP).
Status:	Guidance
Document Type:	Guideline