FDA Issues Final Regulations Requiring the Submission of Information on Pediatric Populations for Devices
This post was written by Paul Sheives.
The Food and Drug Administration (FDA) has issued a direct final rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients. These regulations are promulgated based the mandate in the Food and Drug Administration Amendments Act of 2007. In the absence of any adverse written comments received by FDA before the June 15, 2010 deadline, the agency will publish the effective date of the final rule to be 30 days after the comment period ends.
