Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC office, was quoted in an article titled "Benefits of New Premarket Device Exemptions Not Clear, Attorneys Say."

Following is an excerpt:

Industry attorneys said new guidance announcing FDA's intention to exempt certain low-risk devices from premarket notification requirements could have limited benefits. One attorney said he initially saw the guidance as a "huge boost" to industry, especially mobile health manufacturers, but now believes the ambiguous guidance might not actually exempt as many products as expected.

FDA released guidance Aug. 1 announcing its intent to exempt certain class II and class I medical devices from premarket notifications. The list includes anesthesiology, cardiovascular, dental and gastroenterology devices. FDA said it believed those included were "sufficiently well understood and do not present risks that require premarket notification 510(k) review to assure their safety and effectiveness." Manufacturers of listed devices will not be required to comply with 510(k) requirements during the interim period before FDA issues a final rule or order, nor are they expected to submit 510(k) applications.

Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said stakeholders should be aware that the list of exempted devices might not be as extensive as it appears. He said he initially saw the guidance as potentially being "big news, and a huge boost" to industries like mHealth but upon closer scrutiny said the changes might not be so sweeping.

"I need to moderate my enthusiasm just a bit," Thompson told FDA Week. "When I first read the guidance, I read it to exempt from 510(k) all of the products subject to the listed regulations. But it was very ambiguously written, because it seemed to exempt the products subject to the listed regulations, but then after each one it had the phrase 'including' and then it listed one or more product codes."

Thompson said he has since spoken with FDA staff who have told him that the intent is to exempt just listed products, not the whole regulation. He said that is something industry should be aware of. That nuance is not clearly expressed in the guidance, Thompson said. He added that it would have been helpful if FDA had listed just the product codes that were exempt and not included regulation numbers - potentially causing confusion.

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