The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of Product Evaluation and Quality (OPEQ), following a nationwide search, an FDA spokesperson said Monday.
The OPEQ, in the FDA’s Center for Devices and Radiological Health, manages the premarket review process for medical devices, as well as recalls, inspections and postmarket safety monitoring.
Segan, a former U.S. Army surgeon who has held senior positions at several large medical device companies, began this week, FDA spokesperson Kristina Wieghmink said in an email to MedTech Dive. His appointment was first reported by STAT.
Segan has also been a consultant for medical device companies and was an observer on the board of directors for Delphi Diagnostics, Wieghmink said.
Segan is a former chief medical officer at Olympus Corp. and held executive positions at Johnson & Johnson and Covidien before that, according to his LinkedIn profile. Olympus faced safety issues raised in FDA warning letters over its endoscopes in early 2023. Segan left the company in March 2023, according to his LinkedIn profile.
Most recently, Segan founded and was managing director of Medical Scientific Advisors.
“I am committed to servant leadership and, most importantly, I am passionate about patients having access to innovative medical technology that is clinically relevant, effective, and safe,” Segan said in the email from Wieghmink.
Segan replaces William Maisel, who retired from the FDA this spring after five years as director of the OPEQ and 14 years with the CDRH. Maisel is now senior medical officer at robot maker Intuitive Surgical, according to Maisel’s LinkedIn profile. Owen Faris, principal deputy director of OPEQ, served as the office’s acting director after Maisel’s departure.
Segan joins the CDRH during a time of transition. Jeff Shuren, who led the center for 15 years, stepped down as director this summer. Michelle Tarver, the center’s deputy director for transformation, is now serving as acting CDRH director as the FDA searches for a permanent successor.
Shortly after Shuren retired, The New York Times reported on ethical concerns that arose because his wife, Allison Shuren, represented medical device companies as part of the law firm Arnold & Porter. The FDA defended Shuren’s record after the story was published.
Lawmakers and patient advocates have repeatedly called for the FDA’s product safety system to be strengthened. The FDA’s device recall oversight is the subject of a new U.S. Government Accountability Office review, after Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., last December raised questions about the handling of Philips’ recall of more than 15 million sleep apnea machines and ventilators.
In August, the government watchdog published a report looking at challenges facing the agency’s efforts to expand device safety oversight.
