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.

FDA Medical Device Tracking

This is a guideline regarding tracking of medical devices

Guideline for the Monitoring of Clinical Investigations

The purpose of this guideline is to present acceptable approaches to monitoring clinical investigations

FDA Labelling - Regulatory Requirments for Medical Devices

This document explains label and labelling regulations and requirements for medical devices

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.

COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

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.

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

This document provides guidance on the regulatory review of premarket submissions for software contained in medical devices.

Labelling For Medical Devices

The Guidance describes principles of labelling requirements for Medical Devices.

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