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03. 05.2018

FDA plans reorganized “super office” for device regulation

The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report.

The new office will aim to support a new dynamic and overcome existing separations of functionality within the FDA to create “more organic connections and information sharing,” CDRH head Jeffrey Shuren said, according to the report.

The change comes as the federal watchdog looks to shift its monitoring to taking into account the total product lifecycle of medical devices, RAPS reports, and will fold four previously separate offices into a single entity.

“We’re taking technologies that we put into different offices and move away from a branch structure to instead have teams focused on a specific set of technologies,” Shuren said, according to the report.

Technologies will be separated into six separate departments, with each 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, according to the report.

A separate department will also evaluate in vitro diagnostics and radiological health.

Two departments within the new OPEQ structure will have focuses outside specific technology, with one focused on regulatory programs and one on clinical evidence and analysis, according to RAPS.

The creation of the new OPEQ and its focused departments will continue the FDA’s journey along the three-year roadmap of “strategic priorities” it set out this year leading through to 2020, according to the report. The priorities include achieving an agency staff engagement level of at least 80%, up from a much lower current engagement level of 3%.

The FDA’s Office of Compliance, Office of Surveillance and Biometrics, Office of Device Evaluation and Office of In Vitro Diagnostics and Radiological Health will be primarily impacted throughout the reorganization process, according to the report.

Source: FDA News