William Maisel will retire from the Food and Drug Administration this spring, MedTech Dive has confirmed with the agency.
Maisel has been Director of the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health for the past five years. The office reports directly to CDRH Director Jeffrey Shuren and is responsible for medical device oversight, including premarket authorization, recalls and analyzing medical device reports.
CDRH spokesperson Kristina Wieghmink confirmed Maisel’s retirement in an email to MedTech Dive, adding the agency would conduct a national search to find a replacement.
Maisel, a cardiologist, previously led the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and testified before Congress in 2009 on the need to strengthen the FDA’s approval process for devices. Around that time, lawmakers sought to pass legislation that would protect patients’ right to sue device makers, after a Supreme Court ruling prevented FDA-approved devices from being the subject of personal injury lawsuits.
Maisel joined CDRH in 2010, leading a new science council before heading up the Offices of Device Evaluation and Compliance and serving as chief medical officer.
During his tenure with the FDA, Maisel helped with a reorganization that led to the formation of OPEQ, with the goal of creating a more holistic approach to premarket review and postmarket safety. His office also improved the emergency use authorization process during the pandemic, which served as a pathway to bring tests to market as COVID-19 cases climbed.
The FDA’s recall process has come under scrutiny again in light of Philips’ recall of millions of sleep apnea machines and ventilators. In January, the U.S. Government Accountability Office said it would look into the FDA’s oversight of medical device recalls, following a request from Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn.
Maisel’s time at the FDA was also marked by controversy when he was arrested in a prostitution sting in 2012, according to The Washington Post.
Owen Faris, principal deputy director of OPEQ, will serve as acting director of the office in the interim, Wieghmink wrote. Faris has worked at the FDA for more than two decades, previously as director of the Office of Clinical Evidence and Analysis and as clinical trials director.
