Direct Links to important GMP Medical Device Guidelines
FDA Guide to Inspections of Quality Systems
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).
FDA Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
This guidance serves to assist manufacturers in their development, and to assist Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable.
FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
This guidance document represents the agency’s current thinking on the documentation that should be provided in premarket submissions for medical devices using OTS software.