JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction in the Senate of bipartisan legislation (S.2737) designed to improve the effectiveness of operations at FDA:
“FDA has made great strides in recent years to improve the efficiency, predictability and transparency of its medical technology review process. But we believe that more can be done so that FDA is operating at maximum effectiveness to ensure patients have timely access to medical innovations.
“The steps taken by the Senate HELP Committee in the last two months will help move the agency forward in a positive direction. Legislation introduced by Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) will add to that progress and make needed changes to streamline a number of the agency’s current procedures. The bill would:
· Provide greater predictability and transparency to FDA’s process for recognizing international or national consensus standards;
· Update the law to give the agency the authority to no longer require premarket submissions for a small set of low-risk, Class I products (if FDA deems it appropriate);
· Promote transparency in the process for selecting panel members for FDA advisory committees; and
· Give FDA the authority to pilot alternative methods for improving adverse event reporting.
“We commend Sens. Klobuchar and Roberts for their leadership on these issues and look forward to working with members of Congress, FDA and other key stakeholders on moving this bill forward.”