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Sonali Gunawardhana Discusses 2013 Policy Outlook for Medical Device Makers

Bloomberg BNA
January 24, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed by Bloomberg BNA for an article on this year’s policy outlook for medical device makers.

The industry is awaiting final guidance from the U.S. Food and Drug Administration (FDA) on how it will regulate medical applications (apps) used on smartphones and tablet computers, Ms. Gunawardhana told Bloomberg BNA. The agency proposed in 2011 to regulate only those mobile apps that could put patients at risk if they don't work as intended.

“I think FDA will try to outline more clearly which apps they want to regulate when they issue their final guidance,” said Ms. Gunawardhana, who previously served as regulatory counsel at the agency. “Industry is moving along and the [U.S.] Federal Communications Commission has taken the lead, so it is imperative that FDA also make their intentions known about the issues and how they plan to incorporate medical apps in terms of protection of the public health.”

Another key issue will be new guidance the FDA finalized on December 31, 2012, regarding 510(k) submissions by medical device makers, Ms. Gunawardhana said. Most low- to moderate-risk devices reach the market through the 510(k) process, which allows the products to be approved without human clinical trials if the FDA decides they are substantially equivalent to a device already on the market.

The industry is anxious to see how the FDA’s Center for Devices and Radiological Health (CDRH) revises their 510(k) program in accordance with the new guidelines, Ms. Gunawardhana added.

“Major revisions were called for and I believe industry will need time to adjust as will CDRH reviewers as it will be a new paradigm for review,” she said.