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Michael Causey

FDA Compliance

FDA Accepting Comments on ‘Medical Device Development Tools’

Guidance describes framework and process of voluntary CDRH qualification

Published: Thursday, November 21, 2013 - 17:24

A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools (MDDT).

The guidance, issued Nov. 14, 2013, by the Center for Devices and Radiological Health (CDRH), is designed to facilitate the development and “timely evaluation of innovative” medical devices; it describes the framework and process of voluntary CDRH qualification of MDDT.

An MDDT is a scientifically validated tool—such as a clinical outcome assessment or a test to detect or measure a biomarker—designed to aid device development and regulatory evaluation.

The guidance also includes helpful definitions of key concepts that provide something of a window into FDA’s viewpoint and regulatory expectations. Here are two important examples of how FDA views the world:
• Qualification: A conclusion that within a specified “context of use,” CDRH expects that the results of an assessment that uses MDDT can be relied upon to support device development and regulatory decision making.
• Context of use: “Use” is defined, in part, by the device or product area for which the MDDT is qualified, the stage of device development, and the specific role of the MDDT.


According to the guidance, CDRH is developing a qualification process because it provides a mechanism for leveraging advances in regulatory science, encouraging MDDT development and adoption, and “facilitating faster, more efficient device development and regulatory evaluation.”

However, the guidance intentionally stays away from any specific evidentiary or performance expectations the agency would have for qualifying a specific MDDT.

The FDA is accepting comments and suggestions for revising the guidance until early February 2014. Electronic comments should be sent to www.regulations.gov.

First published Nov. 19, 2013, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.