This post was written by Paul Sheives and Areta Kupchyk.

As Reed Smith previously reported, FDA issued a direct final rule and a corresponding proposed 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. FDA noted at the time that the regulation was promulgated based the mandate in the Food and Drug Administration Amendments Act of 2007. A direct final rule must be withdrawn if the Agency receives significant adverse comments. Because significant adverse comments were submitted, FDA has withdrawn the direct final rule and is considering the comments.