Few medical devices have been specifically approved for use in children. The passage of the 2007 Pediatric Medical Device Safety and Improvement Act was designed to combat the problem of approving of medical devices for use in children without pediatric testing. Despite the government’s intentions, most medical devices approved for pediatric use since the Act was passed have not been tested on children. Almost all pediatric medical devices are solely tested on people age 18 and older.
The FDA requires at least one clinical trial that shows a device is safe and effective before approving it for use with patients; however, trials don’t have to include the same type of patients that will use the device. Pediatrics also spans a very board spectrum from infant to adolescent, and even then kids can vary significantly in growth and development despite their ages.
“Children are not simply ‘small adults,’ and a device … Read More »