Bradley Merrill Thompson, 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 Readies Digital Health Pre-Cert Program for Lift Off,” by David Filmore. (Read the full version – subscription required.)

Following is an excerpt:

Even the highest-risk apps, based on patient condition and significance of information, would be allowed to take advantage of a streamlined review process for companies vetted under US FDA’s oncoming pre-certification program under an initial outline of the program. And many lower-risk apps would see no review to reach market. That’s according to the agency’s newly posted “working model” for the pre-cert program, which the agency plans to launch in its first iteration by the end of the year. …

Industry has been generally supportive of the pre-certification program. The nine pilot firms, including Johnson & Johnson, Roche, Fitbit and Apple, will likely be the first to benefit from the program, but the agency says it plans to expand participants.

While there is a significant focus on establishing an accelerated path to market for companies FDA can trust, at least one digital-health regulatory expert suggests industry should be cautious in reviewing the implications of the plan.

“FDA’s proposing an exchange – faster approvals for more FDA authority,” asserted Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, to Medtech Insight. For instance, Thompson pointed out, FDA has generally said in recent years that it has no intention of regulating low-risk software. But the working model document, he suggests, reverses that in some respects.

In the table (above), “FDA sweeps within its proposed precertification program all SaMD, no matter how low risk,” Thompson notes. “That includes ... software that merely informs a physician of basic information in the context of a nonserious disease. While the FDA proposes to exempt such software from premarket review, the software would be encumbered by all the other burdens of the precertification program including the initial pre-certification and the obligation to collect real-world evidence.”

He also believes that FDA is expanding the scope of company records that it can get access to for pre-certified companies beyond its typical facility inspection authority and that it appears to be expanding its authority for requiring post-market real-world evidence collection.

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