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 “FDA Provides Accessories Guidance, but May Be ‘Missed’ Opportunity,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
But industry was hoping that the final guidance would fill in more information gaps, says Bradley Thompson, an attorney with Epstein Beck Green who represents the Clinical Decision Support Coalition, a group of companies whose technologies often work with other devices.
The guidance isn’t the agency’s “best work” and leaves a lot of unanswered questions, Thompson laments.
“I suppose, by definition, any article that does not do one of those three things is therefore not an accessory,” he told Medtech Insight. “But FDA spent almost no ink explaining what the world outside of those categories looks like. Repeatedly, commenters requested more examples and more explanation for product categories such as connected health.”
Thompson says the lack of clarification, in his view, is challenging to manufacturers that may not be confident what the agency expects of them.
“FDA missed the opportunity to help industry by responding to comments requesting more examples,” he added. “It would’ve been a relatively simple matter to go through a list of common products and explain how that three-part test is applied. Despite the request in the comments, FDA did not do so.”