ODE Reorganization Reduces Reviewer-To-Manager Ratio
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
FDA Office Of Device Evaluation: People, Products On The Move
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.
CDRH’s Division of Cardiovascular Devices Starts 30-Day Notice Reviews
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.
Multiple MDUFA Policies In Transition Phase Until Jan. 1
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.