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September 2014
Policy and Advocacy
IDSA Submits Comments to FDA on Draft Guidance on Diagnostics
The Food and Drug Administration (FDA) recently issued draft guidance important to the development of new diagnostic tests. IDSA submitted comments to the first FDA draft guidance that calls for an expedited approval process for medical devices that can meet unmet medical needs.  IDSA praised the agency's new provisions for diagnostic device trials, such as the use of banked samples from previous studies as well as contrived samples to test the clinical effectiveness and safety of diagnostics for rare diseases. IDSA believes this guidance will greatly facilitate the rapid development and review of innovative diagnostics and significantly impact patient care.

IDSA also submitted comments (PDF) to a second FDA draft guidance that allows small clinical studies in the approval process of diagnostics that address unmet medical needs. Acknowledging that smaller trials may leave more uncertainty about the risks and benefits of these tests, the guidance indicates that additional data can then be collected post-approval to provide information about the diagnostic’s efficacy and appropriate use in real-world settings. IDSA supports the provisions for post-market data collection that will allow novel tests to reach patients more rapidly.

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