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 the Bloomberg BNA Medical Devices Law & Industry Report, “Device Makers Get FDA Guidance on Premarket Clearances,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Device makers now have final guidance from the FDA on when they should submit a new premarket clearance request for existing products. …
While the final guidance documents may be helpful, what’s really needed is a change in FDA regulation, Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington, told Bloomberg Lawin an Oct. 24 email. Thompson represents device and life science companies and is a Bloomberg Law advisory board member.
The mobile health industry is concerned that they will have to keep FDA clearances up-to-date with every change they make in software, Thompson said. “Software development is highly iterative based on feedback, and the idea of seeking FDA clearance for every improvement makes many entrepreneurs sick to their stomachs,” he said.
Thompson said the FDA’s precertification pilot program, if adopted through a new regulation, would override the old regulation. The FDA unveiled the pilot program in a July 28 Federal Register notice (FDA–2017–N–4301). The goal of the program is to allow precertified companies to submit less information to the FDA than is currently required before marketing a new digital health tool.
“The new approach is an entirely different paradigm, where FDA focuses on the qualifications of the software vendor, rather than the specific features of the software program,” he said. “By ensuring that software developers are fully capable of producing the highest quality software, FDA can streamline the process not just to market initially, but the process of iterating new software products over time.”
Thompson said industry would like the FDA to focus its time and attention on the precertification program. “That’s where the greatest opportunities for improvement reside,” he said.