EBG Commentary

Bradley Merrill Thompson Quoted in “Legislation Would Streamline Risk-Classification for Device Accessories”

Medtech Insight

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “Legislation Would Streamline Risk-Classification for Device Accessories,” by Ferdous Al-Faruque. (Read the full version – subscription required.)

Following is an excerpt:

Bradley Thompson, who practices law at Epstein Becker & Green in addition to his work with the Clinical Decision Support Coalition, has been lobbying FDA to change its oversight of accessories since 2010. The attorney says the agency’s views on regulating accessories has evolved, especially with the latest guidance document, where it agreed their classification should be based on intended use. But he notes it still left out the question of what process FDA should use to regulate the products. That issue would apparently be addressed by Walters and Kuster’s bill, he suggested.

“This bill picks up where 21st Century Cures left off with the premise that accessories should be classified on the basis of their own intended use, rather than the intended use of the parent device,” Thompson told Medtech Insight. “What the act then seems to do is create at least three alternative pathways for accomplishing that classification, instead of the de novo process.”

Thompson says the new proposed pathway is progress, but he is somewhat skeptical about how big of an impact the bill could have on the status quo.

“Right now, if FDA agrees to a classification through a pre-market approval process, I don’t know that there’s any particular barrier to them setting up a new classification that they’ve already essentially acknowledged,” he said. “By far the tougher issue, and the issue that this legislation does not address, is the standard for deciding the appropriate classification.”

The biggest issue for Thompson is figuring out what level of evidence FDA will require of accessory manufacturers to determine the product’s risk class. Essentially, that issue is skipped in the new legislation and is deferred to FDA.