The US Food and Drug Administration’s (FDA) Center for Devices and
Radiological Health (CDRH) has announced plans to create an outside
network of scientific experts to advise agency staff on device
approvals. In addition, CDRH has simultaneously launched a 12-week pilot
of the network that will run through 30 December 2011 and is soliciting
public comment. The experts “would provide staff with rapid access to
specific specialized knowledge about emerging technology, as well as
other topics,” according to a statement from FDA, but would not provide
opinions or advice, allowing agency reviewers to draw their own
conclusions. The program is part of FDA’s efforts to improve its 510(k)
review process.
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