A new Food and Drug Administration (FDA) draft guidance, “Medical Device Development Tools—Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff,” outlines a voluntary process for qualification of medical device development tools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

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