Bradley Merrill Thompson Quoted in “New FDA Guidances Aim to Increase Clarity on When Developers Need to Resubmit 510(K)s”


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 MobiHealthNews, in “New FDA Guidances Aim to Increase Clarity on When Developers Need to Resubmit 510(K)s,” by Jonah Comstock.

Following is an excerpt:

The FDA released two final guidances and a new draft guidance today to increase the regulatory clarity around medical devices, including software as a medical device. The agency also announced the first qualified tool under the voluntary Medical Device Development Tools (MDDT) program. …

Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA regulation of mobile and digital health, told MobiHealthNews that the move is welcome, but likely doesn't go far enough.

“When I talk to people in the mHealth industry, while none of them are thrilled with the idea of getting FDA clearance for their mobile apps, what they really fear is the obligation from that point forward to keep the FDA clearance up-to-date with changes in the software,” he said in an email. “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. FDA seems to be getting that message.”

The problem, Thompson says, is that there's only so much the FDA can do within its own rules, which dictate a lot of circumstances in which a device needs new clearance. This new guidance only draws attention to the need for something like the FDA Pre-Certification Program, which, if it successfully moves past the pilot phase, would alleviate the need for these sorts of updates completely.

“The new guidances announced today for device modifications may be helpful, but we won’t know that really until we’ve studied the very specific language and see how it allows for important software updating to occur with minimal FDA oversight,” Thompson said. “But if it’s an improvement, it’s only a marginal one. Until we change the regulation and shift the agency’s focus to the software vendor, rather than engaging in individual product review, any gains will be small at best.”