Senate bill would streamline FDA’s medical device reviews

Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced S.2737, or “A bill to improve medical device innovation,” to the Upper Chamber’s Health, Education, Labor & Pensions committee March 17.  Earlier that month, the panel advanced a trio of bills aimed at the federal safety watchdog, that would create a fast-track program for breakthrough devices, clarify the agency’s oversight of combination products and codify the regulations for software-using devices.

J.C. Scott, Senior Executive Vice President for Government Affairs at AdvaMed, said the new Klobuchar/Roberts bill would make clear the FDA’s process for recognizing consensus standards here and internationally.  A provision would also give the agency more discretion for allowing low-risk, Class I devices to forego pre-market approval submissions; another would make the appointment of FDA advisory panel members more transparent, Scott said.  The bill would also allow the FDA to pilot alternative adverse event reporting systems, he said.

“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,” Scott said in prepared remarks.  “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.”

REFERENCE:  Mass Devices; 21 MAR 2016; Brad Perriello

Leave a Comment