Bradley Merrill Thompson Quoted in “FDA Still Trying to Fine-Tune Pre-Cert as Pilot Enters 2020”

Medtech Dive

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “FDA Still Trying to Fine-Tune Pre-Cert as Pilot Enters 2020,” by Greg Slabodkin.

Following is an excerpt:

The FDA initiative, led by Patel, seeks to reduce certification hurdles for developers of software-based medical devices by shifting responsibility for periodic software updates to manufacturers themselves.

But the uncertainty around the Pre-Cert program and the agency’s plans for regulating digital health technologies is making some industry observers nervous.

Bradley Merrill Thompson, a medical device regulatory attorney at Washington, D.C.-based Epstein Becker Green, says while he appreciates FDA taking its time and “trying to be careful,” the progress of the Pre-Cert pilot has been “very slow.” In particular, Thompson is concerned the agency hasn’t worked out the specific statutory authority required.

“FDA can’t ask Congress for authority to just do whatever the agency wants to do in its judgment. We need certainty and predictability, and we need to make sure that the agency doesn’t go awry,” Thompson said. “So FDA needs to get this figured out before they ask for statutory authority to implement it.” …

But in Thompson’s view, it’s a “huge problem” for FDA to start asking for lots of postmarket data, while making the case the agency will never know as much about individual products as the companies that make them.

“Data always needs to be put in context. Raw information would likely be frequently misunderstood by FDA, and contextualizing raw information is a significant amount of work for the software developer to undertake,” Thompson said. …

However, Thompson asserts the “so-called nuances” that Patel refers to are actually the most important parts of the FDA’s Pre-Cert program for developers that must have specific details.

“It’s relatively easy to talk in general terms about philosophy. It’s very difficult to translate that into something workable,” Thompson said. ”I think FDA has more than just mere nuances to work through at this juncture. They have fundamentally important issues to figure out.”