Federal Register supplemental notice of proposed rulemaking: FDA published a proposed rule in the 4/1/10 Federal Register along with a companion direct final rule to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations. The agency received significant adverse comment and withdrew the direct final rule. It is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received. To view this notice, click here.