FDA Floats Plan For Streamlined Device Evaluation

Law360, New York (November 13, 2013, 8:27 PM EST) -- The U.S. Food and Drug Administration on Wednesday unveiled a draft proposal for streamlining approval of medical devices, saying it wants to standardize tools used in clinical trials to measure product effectiveness.

In a 26-page guidance document, FDA focused on so-called medical device development tools, such as rating scales and medical images, that gauge a product’s usefulness during pre-approval studies.

As it stands, FDA often revisits the same tools time and again if they're used with different products or in different settings. Under the new approach, the...
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