Pathways' Pick of the Week: CDRH Updates

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ARTICLE SUMMARY:

Organizational changes at FDA’s device center. Excerpted from Pathways’ Picks March 8: EU MDR Survey, US Clinical Terms, UK AI Focus, and More.

CDRH is adding three new divisions within its Office of Product Evaluation and Quality (OPEQ) under an organizational structure update disclosed May 7. The additions, which became effective in January, include two new divisions (Divisions IV and V) in OPEQ’s Office of Clinical Evidence and Analysis and a third division added to the review office focused on surgical and infection control devices (Office of Health Technology IV). The May 7 notice doesn’t specify the precise focus of the new divisions. The Office of Clinical Evidence and Analysis generally supports policy development for clinical trials, real-world evidence, biostatistics, and related programs. 

On the same day, CDRH disclosed a renaming and reorganization of its Office of Communication and Education, which also took effect in January. The new Office of Communication, Information Disclosure, Training, and Education (OCITE) has been restructured with two main sub-offices—one addressing Communication and Content Development and the other overseeing Training and Education. The office broadly handles outreach programs to external audiences, including to the regulatory industry, and training for CDRH employees. 

The device center recently created two new supervisory positions to run its Total Product Life Cycle (TPLC) Fellowship Program. Dawn White, who runs OPEQ’s Professional Development division, and Jennifer Brown have been tapped as acting team leads for the program that launched in 2022 to recruit recent science and engineering graduates to receive training and mentorship on the FDA’s device review program.

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