Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority,” by Mark McCarty. (Read the full version – subscription required.)

Following is an excerpt:

The U.S. FDA’s final report for the software pre-certification (pre-cert) pilot program for software as a medical device (SaMD) highlighted a number of both positive and negative developments, but the agency reiterated its call for new statutory authorities for review of SaMD. However, the agency also acknowledged that the pilot was itself compromised by the absence of that statutory authority because the absence of such authority means that the results of these mock product reviews cannot be legally walled off from non-pilot applications. …

Brad Thompson of the D.C. office of Epstein, Becker & Green PC, told BioWorld that he has been raising the question of the legality of the pre-cert pilot from the outset. Thompson said that while CMS does enjoy the statutory authority to conduct a pilot program, the FDA does not, and thus any output from the mock reviews was legally indistinct from any reviews conducted outside the pilot.

Thompson said one possible explanation for this seemingly irresolvable legal dilemma suggests that the FDA may not have thought the concept through when it added mock de novo reviews to the pilot. The report includes several concessions about aspects of the pilot that proved clunky at best, but Thompson said industry may have felt that moderate-risk devices would at least not be subject to a more time- and resource-consuming process than the typical de novo review.

The results suggest that this is not the case however, and Thompson noted that while the idea for the pre-cert program came from senior staff at the FDA’s device center, product reviewers might not have been enamored of using the culture of excellence as a proxy for a premarket review for class II, medium-risk devices. ...

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