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Sonali Gunawardhana Discusses 2015 Policy Outlook for Medical Device Industry

Bloomberg BNA
January 22, 2015

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted yesterday in a Bloomberg BNA article about the top issues that will affect the medical devices industry in 2015.  Those issues include legislation to repeal the excise tax on medical devices, and the Food and Drug Administration’s (FDA) use of the de novo process to allow devices on the market.

Ms. Gunawardhana is a member of the advisory board for BNA’s Medical Devices Law & Industry Report. She was among board members who said the Republican majority in both houses of Congress makes a device tax repeal more likely, but there is still no guarantee it will happen. 

“I believe it has its best chance this year given the change to a Republican-dominated Senate, but, as with everything that Congress looks at, it could be sacrificed for something else of importance,” Ms. Gunawardhana said.

She also predicted that the FDA may increase its reliance on the de novo process as more innovative devices are developed.  “Hopefully, the time frames for review will shorten as well, given an influx of submissions,” Ms. Gunawardhana said.