This document provides guidance to the FDA
field staff on a new inspectional process that
may be used to assess a medical device
manufacturer’s compliance with the Quality
System Regulation and related regulations.
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles.
This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA).