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Patricia O'Connell
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Sonali Gunawardhana Discusses 510(k) Policies for Medical Device Modifications

FDA News’ Devices & Diagnostics Letter
June 19, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted by FDA News' Devices & Diagnostics Letter in a June 17 article about the U.S. Food and Drug Administration’s (FDA) policies regarding 510(k) submissions by medical device companies. The agency is considering changes to the 510(k) program.

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 agency held a public workshop last week, hearing comments from stakeholders on when companies should be required to submit a new 510(k) for modifications to marketed devices. The medical device industry opposes major changes to the FDA’s existing 510(k) policies for product modifications, and urged the agency not to adopt the provisions outlined in the 2011 draft guidance document that would have increased the number of required 510(k) submissions, according to the article.

The 2011 draft guidance document—which was later withdrawn by the FDA—failed to address specific concerns regarding software used in medical devices, Ms. Gunawardhana told the agency during the June 13 workshop; her public comments were cited in the FDA News article. The FDA withdrew the 2011 proposal after Congress ordered the agency to seek input from stakeholders before issuing a revised draft.

If the FDA ends up adopting its proposed 2011 draft guidance language, some medical device makers may decide not to fix minor, unanticipated software bugs discovered in marketed products, because doing so might trigger the need to submit a new 510(k), Ms. Gunawardhana said.

“This will only stymie improvements and enhancements that lay the groundwork for future innovation,” she said in her prepared remarks to the FDA.

To read the text of Ms. Gunawardhana’s comments at the FDA workshop, click here.

To view a webcast of the FDA workshop, including Ms. Gunawardhana’s comments, click here.