Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Regulatory updates from FDA and the White House.
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ODE Reorganization Reduces Reviewer-To-Manager Ratio
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.
Pediatric Imaging: Industry Questions Need For Warning Labels
The Medical Imaging & Technology Alliance does not want FDA to require warning labels for X-ray-based imaging machines that have not been tested for pediatric use.
Better Radiation Dose Estimates Needed For Pediatric Imaging, Docs And Industry Agree
At a recent FDA meeting on pediatric X-ray imaging, clinicians and manufacturers discussed the importance of developing size-specific dose estimates to improve children’s safety.