Regulatory News In Brief

President Obama signed the FDA Safety and Innovation Act into law July 9, after the House and Senate passed the legislation in June. The law includes reauthorization of the FDA user fee program for medical devices for fiscal 2013-2017, as well as reforms to streamline FDA’s regulatory authority and improve patient safety. “This legislation … will help speed safe and effective medical products to patients and maintain our nation’s role as a leader in biomedical innovation,” HHS Secretary Kathleen Sebelius said in a July 9 statement. The current user fee program expires Sept. 30, and the new fees go into effect Oct. 1. (See Also see "FDA Subject To More Oversight Following User Fee Bill Passage" - Medtech Insight, 2 July, 2012..)