FDA Medical Device Reporting for Manufacturers

Title:
FDA Medical Device Reporting for Manufacturers

https://www.gmp-compliance.org/files/guidemgr/Medical-Device-Reporting-for-Manufacturers---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff (2).pdf

Origin/Publisher:

FDA

Content:
This guidance document describes and explains FDA´s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

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