ARTICLE SUMMARY:
The dynamics of medtech regulation in the US have transformed significantly over the past 15 years under the leadership of Jeff Shuren, who stepped down as CDRH director in July. Here’s our first look at some important themes and some lingering questions from Shuren’s tenure.
[Editor’s notes: See past interviews conducted by Market Pathways with Jeff Shuren in the “Related Content” section, in the right-hand column.]
Jeff Shuren took the helm at CDRH during a tense and vulnerable time for US medical device regulation.
It was September 2009 and public calls to completely rebuild or outright abolish the 510(k) program were reaching a fever pitch (see sidebar below, “510(k) Focus”). A group of CDRH scientists were writing to Congress and incoming president Barack Obama to complain that device center management was coercing reviewers. Meanwhile, the medical device industry was expressing growing frustration with the delays and lack of predictability and transparency in the premarket review process.
Just shy of 15 years later, Shuren, the longest-serving director in CDRH’s 40-plus-year history, is stepping down from a much-transformed center. Shuren relinquished his role as CDRH director on July 28, when CDRH veteran Michelle Tarver, Deputy Center Director of Transformation, took over as acting director. Shuren will stay on at FDA until later in the year to help with the transition and as the agency conducts a nationwide search for a successor.
During his time leading CDRH, he has overseen a dizzying array of new programs and reforms and is frequently credited by device industry leaders for reshaping the center into a more efficient, transparent, and pro-innovation regulator. (See “Jeff Shuren, 10 Years in at CDRH, Wants More Space to Innovate,” Market Pathways, June 27, 2019.)
To be sure, plenty of debate remains about medical devices and how they are regulated. The device industry and the agency don’t exactly see eye to eye on everything. Public health researchers and consumer advocates continue to argue FDA oversight of device safety is lacking. And the COVID-19 pandemic challenged the center to its core and put it under a harsh spotlight. But Shuren is widely credited in the medtech sector with stabilizing the center, elevating its reputation on the global stage, and taking important steps to transition it into the digital age.
