FDA proposes randomized, controlled testing for incontinence devices

10/5/2008 | FDAnews

The easiest way to obtain data on the safety and effectiveness of urinary incontinence devices is to conduct randomized, controlled clinical studies, according to an FDA draft guidance. Such trials can help overcome major issues in testing the products, including the diversity of the general patient population. The agency will accept comments on the draft until Dec. 18.

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