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 “What Does Gottlieb’s Resignation Mean for Medtech?” by David Lim and Maria Rachal.
Following is an excerpt:
Under Gottlieb’s tenure FDA rolled out a number of medical device initiatives, some mandated by the landmark 21st Century Cures Act, such as guidances on breakthrough devices, CLIA waiver improvements and burdensome device review.
Other policies, such as the agency’s proposal to examine limiting manufacturer reliance on 510(k) predicate devices older than 10 years came in the midst of criticism the agency is too lax in its regulatory oversight.
But Gottlieb often left device decision making to Shuren, a sign he trusted the career staffer to run the show.
“At CDRH, really what he was doing was letting Jeff Shuren do his thing. It was Jeff driving it and Gottlieb giving him permission to do so,” Brad Thompson, a digital software attorney at Epstein Becker & Green, told MedTech Dive. “I don’t mean to minimize that. There are some commissioners who would have said no, just saying yes to Shuren was significant.” …
It’s unclear who will take Gottlieb’s place, but some in industry fear a less conventional, more typical Trump administration candidate. During the last FDA chief search, the rumored nomination of Peter Thiel associate Jim O’Neill, who advocated against mandating companies prove the effectiveness of new products, spooked some.
Bakul Patel, FDA associate center director for digital health, is another CDRH leader who shepherded the Pre-Cert Program from conception to its current proposal. His presence will maintain additional normalcy at CDRH, according to Thompson.
