Bradley Merrill Thompson Quoted in “Industry Lawyer Says FDA-Proposed Device Accessory List Too Short”Inside Health Policy August 16, 2018
Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Industry Lawyer Says FDA-Proposed Device Accessory List Too Short,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
An industry lawyer said a newly proposed list of device accessories that FDA thinks could be re-classified as low-risk does not fully embrace requests from industry and a directive from Congress to reduce the regulatory burden related to certain device accessories. Brad Thompson, a member of the firm at Epstein Becker Green, said the list only includes 10 categories of device accessories, nearly all of them in the fields of gastrology or urology.
“Given the number of device categories that FDA regulates, that’s not much of a change,” Thompson told Inside Health Policy. “I was hoping that FDA would use this opportunity to down classify certain clinical decision support software that I think is overregulated.” …
Though Thompson did not comment on the other two initiatives, he explained that when Congress passed the FDA Reauthorization Act of 2017, section 707 of the act directed the agency to propose a list of accessories suitable for classification in Class I, the lowest risk category for devices. Thompson said reclassification has been a big issue for digital health industry members, who the lawyer said have grown familiar with certain accessories and realized that they are low risk.
“FDA on its own down classified medical device data systems all the way into the enforcement discretion category before Congress stepped in and declared them to be no longer medical devices,” Thompson provided as an example.