MedTech Dive first reported the news on Feb. 15. An FDA spokesperson confirmed Maisel’s planned retirement via email. He spent more than 14 years with CDRH, including more than five years as director of OPEQ.
According to the spokesperson, Maisel plans to retire in the spring. CDRH plans to conduct a national search to fill his position.
In the interim, the FDA plans for Dr. Owen Faris to serve in an acting capacity as director of OPEQ. Faris currently serves as principal deputy director of Opeq and has spent more than two decades at the FDA. His previous roles include director of the Office of Clinical Evidence and Analysis and the clinical trials director, in addition to his current role in OPEQ.
OPEQ’s website says the office “assures patients have access to high quality, safe and effective products throughout the total product lifecycle.” It implements the program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. That includes 510(k) clearances, premarket and de novo approvals and investigational device exemptions, among others.
The office also says it protects and promotes public health by evaluating, enhancing and ensuring compliance with medical device laws through recall, inspection and audit, registration and listing, allegations of regulatory misconduct, import, export, premarket and labeling and bioresearch monitoring programs.
OPEQ also holds responsibility for ensuring the continued safety and effectiveness of medical devices after they reach the marketplace.
