This week, representatives Ed Markey (D-Mass.) and Mike Rogers (R-Mich.) introduced a bill that would require medical device makers to include pediatric information in some application they submit to FDA. The proposed rule is part of H.R. 3975, The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012, which seeks to reauthorize the Pediatric Medical Device Safety & Improvement Act of 2007.

FDA previously introduced such a rule in 2010, but it was so controversial the agency withdrew it, writes Jennifer D. Newberger on the FDA Law Blog. You can learn more about the bill on the blog.