The FDA Center for Devices and Radiological Health officially launched its new “super office”, the Office of Product Evaluation and Quality, on Wednesday, according to a report from the Regulatory Affairs Professionals Society.
The newly launched division continues the federal watchdog’s shift to a total product lifecycle (TPLC) approach to regulatory oversight, covering premarket reviews, postmarket surveillance and enforcement through specific teams, according to the report.
Technologies will be separated into six separate departments, with each team focusing on a set of devices.
Ophthalmic, anesthetic, respiratory, ENT and dental devices will make up the first division, cardiovascular devices will make up the second, and reproductive, gastro-renal, urological, general hospital devices and human factors will make up the third. The fourth division will focus on surgical and infection control devices, the fifth on neurological and physical medicine devices and the last will focus entirely on orthopedic devices.
A separate department will also evaluate in vitro diagnostics and radiological health.
While the FDA’s CDRH has been operating under a total product lifecycle approach, it has not been structured to support the approach fully, according to the RAPS report.
“No more running to different offices, no more running to different people,” CDRH head Jeffrey Shuren said about OPEQ, according to the report.
The FDA announced its plans to launch the new “super office” last May.