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Patricia O'Connell
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Sonali Gunawardhana Discusses 2014 Regulatory Outlook for Medical Device Industry

Bloomberg BNA
January 23, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted yesterday by Bloomberg BNA’s Medical Devices Law & Industry Report in an article about the U.S. Food and Drug Administration’s (FDA) 2014 agenda.

The industry’s main priority will be persuading Congress to repeal the 2.3 percent excise tax on devices that took effect last year, according to the article.  The tax is problematic for small device companies that sell most of their products domestically, Ms. Gunawardhana told Bloomberg BNA.

She added that while the FDA will probably take some action on 510(k) submissions this year—with respect to a 2011 draft guidance that was later withdrawn—it may not come out with new 510(k) guidance this year.  She also predicted that there will be “more clearances/approvals through the de novo process and overall collaboration between the FDA and industry in areas where there is a medical need for innovative device solutions.”

The FDA may also issue guidance on laboratory-developed tests in 2014, and is likely to release a device-specific draft guidance in the social media area, Ms. Gunawardhana said.

She also predicted that the FDA’s Center for Devices and Radiological Health (CDRH) could place more emphasis this year on promotional issues.  “We may see a surge in compliance activities including warning letters” in the area of television and print advertising and promotion of medical devices as a result of the reorganization of CDRH’s Office of Compliance, Ms. Gunawardhana said.