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Patricia O'Connell
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Sonali Gunawardhana Discusses D.C. Circuit Ruling on Menaflex Device Reclassification

Bloomberg BNA’s Medical Devices Law & Industry Rep
October 2, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted in a Bloomberg BNA article about the D.C. Circuit’s September 26 ruling that the U.S. Food and Drug Administration (FDA) did not follow proper statutory procedure when it reclassified the controversial Menaflex Scaffold medical device.  The court vacated the FDA’s decision to rescind a 510(k) substantial equivalence determination for the product because Congress created a procedure to reclassify the device which the agency’s Center for Devices and Radiological Health did not implement appropriately.

The FDA will probably be more cautious with such decisions in the future, Ms. Gunawardhana said in the September 29 article.  “I don’t think you’ll see an order rescinding its clearance decision being made in the same manner,” she said.  “I think they’ll utilize the notice and comment rulemaking avenue until the proposed rule regarding reclassification through administrative order is finalized.”

She added that the FDA’s Menaflex decision involved “an irregular issue regarding the review process that most likely will not be repeated,” because Congress has since given the agency more tools to deal with similar situations.