ARTICLE SUMMARY:
In this week’s Pathways Picks: CDRH’s long-time director Jeff Shuren announces his retirement; FDA digs deeper on reimbursement; FDA funding bill slows; China publishes new procedures for importing urgent-use, unapproved devices; El Salvador moves forward on super agency; and more global medtech policy updates.
Editor’s note: Pathways Picks will not be published next week, July 31. Always find in-depth reporting and insights on medtech regulatory, reimbursement, and policy issues on our website.
Top Pick: Jeff Shuren Departs
The longest-serving director in CDRH’s history is stepping down at the end of this week. Jeff Shuren informed staff that he was leaving FDA after 15 years leading the device center (and more than 25 years at the agency). He will remain at FDA until later in the year to help with the transition, as Michelle Tarver, CDRH’s deputy center director of transformation, takes over as acting director and FDA conducts a nationwide search for a permanent device center chief.
Shuren has overseen a dizzying array of new programs and reforms during his tenure 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.)
He also led CDRH through the pandemic, and he may have stepped down a little sooner if not for a decision to stay on to help steer the ship during the public health emergency, Shuren suggested in his July 23 memo to staff. “Today, the pandemic is in our rearview mirror, our Center is not only back on track, but I think better positioned and stronger than ever before, and our current vision has been achieved,” he wrote. In the letter, he underscored the record number of innovative devices that have gone through the center annually under his watch and celebrated the goal met of having a majority of manufacturers of new novel devices now bringing their devices to the US first or in parallel with other markets. “Today we are viewed as a leader in the medical device ecosystem both at home and abroad.”
Tarver, who is an ophthalmologist and epidemiologist, has been with CDRH since 2009. She has spent significant time leading the center’s patient science and engagement efforts and was elevated to the broad-remit “transformation” role last year. She will take the helm July 28, when Shuren will transition to the FDA commissioner’s office for several months as “center director emeritus” to aid the transition before retiring from the agency.
