Regulatory News In Brief

The Senate is catching up to the House in introducing FDA device bills that could come into play during next year’s user-fee reauthorization process. Two bills were introduced last week in the Senate that are companion measures to legislation introduced in the House in October. On Dec. 5, Sens. Scott Brown, R-Mass., and Kelly Ayotte, R-N.H., introduced the Novel Device Regulatory Relief Act of 2011 (S. 1943), which aims to streamline FDA’s de novo classification process for devices. Specifically, the bill would remove the requirement that sponsors first submit a 510(k) and receive a “not-substantially equivalent” (NSE) determination before pursuing the de novo route, matching a bill of the same name introduced Oct. 14 in the House by Rep. Brian Bilbray, R-Calif. (See Also see "Flurries Of New Bills Advance Device Industry Interests In Congress" - Medtech Insight, 17 October, 2011..) FDA is attempting to streamline the process through guidance development by working around the NSE requirement. (See [A# 01111010001].)

Then, on Dec. 8, Sens. Dan Coats, R-Ind., and Ayotte introduced the FDA Mission Reform Act (S. 1972), which adds new provisions to FDA’s statutory mission, with a focus on...