CBER Developing Device Action Plan In Effort To Model CDRH Review Changes
This article was originally published in The Gray Sheet
FDA's Center for Biologics Evaluation and Research should adopt many of the practices used by the Center for Devices and Radiological Health, such as the abbreviated 510(k) process, to speed the review of devices regulated by CBER, industry participants said at a Dec. 1 FDA-sponsored meeting on the subject.
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