CDRH dispute resolution guidance
This article was originally published in The Gray Sheet
Publication is anticipated in the next couple of weeks, Center for Devices and Radiological Health Director Bruce Burlington reports at the FDLI annual meeting Dec. 16. The document is expected to state that members of FDA's Medical Device Advisory Committee will be called upon when necessary to address device-related scientific controversies ("The Gray Sheet" July 6, p. 17). A plan to name a CDRH ombudsman to assist in the review of such matters has been put on hold because of budget constraints, staffers say
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