FDA releases draft guidance for trials of incontinence devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, September 26, 2008
Medical device manufacturers should use a randomized, controlled trial to collect data to demonstrate the safety and effectiveness of urinary incontinence devices, according to FDA draft guidance.
Clinical studies may not be needed for most class I and II urinary incontinence devices, but FDA recommends manufacturers collect clinical data for class I and II urinary incontinence devices with any one of the following:
- Indications for use dissimilar from a legally marketed device of the same type
- Designs dissimilar from designs previously cleared under a premarket notification
- New technology
Manufacturers need clinical data with valid scientific evidence for class III devices. The guidance includes a list of devices and their classifications. The FDA also details how manufacturers should design and conduct studies.
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