ODE Reorganization Reduces Reviewer-To-Manager Ratio
This article was originally published in The Gray Sheet
A restructuring in the Office of Device Evaluation, incorporating dozens of new hires, is intended to reduce the number of reviewers reporting to each manager. It took effect last week.
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With a recent reorganization and user-fee-program ramp-up, there is a lot of hiring and promotion activity at ODE, and also some occasional head scratching about a device’s appropriate review-branch home, according to Christy Foreman, who directs the office that serves as a U.S.-market gatekeeper for many medical devices.
The division officially began taking over reviews of 30-day manufacturing notices from the Office of Compliance Feb. 1 as part of a larger reorganization.
For now, CDRH remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k) submissions and its mandate for electronic copies of pre-market submissions, each of which have been addressed in recent guidance documents.