Beginning in August, the US Food and Drug Administration (FDA) will require manufacturers of medical devices to submit information to the agency about the pediatric populations affected by the condition their device treats. Currently, few medical devices on the market have been designed or studied specifically for use in pediatric patients, the agency noted.
The Food and Drug Administration Amendments Act of 2007 created the new requirement, and the agency is now amending its regulations to implement this portion of the law. More information is available in the Federal Register (http://edocket.access.gpo.gov/2010/2010-7193.htm).
Kuehn BM. Pediatric Device Information. JAMA. 2010;303(20):2022. doi:10.1001/jama.2010.644
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: