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GUIDANCE DOCUMENT

Qualification of Medical Device Development Tools Guidance for Industry, Tool Developers, and Food and Drug Administration Staff August 2017

Final

Qualification of Medical Device Development Tools

Docket Number:
FDA-2013-D-1279
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document provides guidance on a voluntary program for qualification of medical device development tools (MDDT) for use in evaluating devices subject to regulation by Center for Devices and Radiological Health (CDRH). CDRH believes that this policy will facilitate the development and timely evaluation of medical devices, by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1279.