The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Medical Device Reporting: An Overview
Origin/Publisher:
FDA
Document Type:
Overview
Content:
This document is intended to help manufacturers and user facilities understand the basic requirements for reporting adverse events involving medical devices as required by the
Medical Device Reporting (MDR) Regulation (Title 21, Code of Federal Regulations, Part
803).
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