FDA Says Device Makers Must Provide Pediatric Data

Law360, New York (February 19, 2013, 6:26 PM EST) -- The U.S. Food and Drug Administration on Tuesday proposed that medical device manufacturers must provide information on pediatric patients who might benefit from their equipment, a move intended to boost production of medical devices geared toward children and spot potential risks to younger Americans.

Few devices are produced specifically for youths, and the requirement for companies to detail the number of Americans ages 21 and under who suffer from diseases their technology targets is primarily meant to help the FDA identify unmet pediatric needs.

"Once unmet needs...
To view the full article, register now.