FDA Quality System Information for Certain Premarket Application Reviews, Guidance for Industry

Title:
FDA Quality System Information for Certain Premarket Application Reviews, Guidance for Industry

https://www.gmp-compliance.org/files/guidemgr/Quality-System-Information-for-Certain-Premarket-Application-Reviews---Guidance-for-Industry-and-FDA-Staff (1).pdf

Origin/Publisher:

FDA

Document Type:
Guideline
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).

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