Direct Links to important GMP Medical Device Guidelines

Principles of Labelling for Medical Devices and IVD Medical Devices

The purpose of this IMDRF guidance is to provide globally harmonized labelling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support the IMDRF Essential Principles of Safety and Performance'.

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Clinical Evidence - Key Definitions and Concepts

It is anticipated that convergence of requirements for clinical evidence, including common data submissions, will lead to better understanding of medical device safety, clinical performance and/or effectiveness by all stakeholders, more efficient use of resources of the clinical community, medical device regulators and industry, and increased transparency and confidence in the global regulatory model.

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Clinical Evaluation

The primary purpose of this document is to provide manufacturers with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing.

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Clinical Investigations

The primary purpose of this document is to provide guidance in relation to when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles and the general principles of clinical investigation involving medical devices.

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Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments

mit a request for nonbinding feedback to FDA regarding actions the firm has proposed to take to 111address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firm’s establishment.

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FDA Guidance for Industry: Multiple Function Device Products: Policy and Considerations

Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures Act (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to add section 520(o), which excludes certain software functions from the definition of device in section 201(h)of the FD&C Act

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Clinical Studies

he document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.

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Principles and Practices for Medical Device Cybersecurity

This document is designed to provide concrete recommendations to all responsible stakeholders on the general principles and best practices for medical device cybersecurity (including in vitro diagnostic (IVD) medical devices).

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GMP Conferences by Topics

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