Abbreviated 510(k) review for devices subject to recalls planned by FDA.
This article was originally published in The Gray Sheet
ABBREVIATED 510(k) REVIEW FOR DEVICES SUBJECT TO RECALLS is planned by FDA under an internal policy document being finalized at the agency's Center for Devices and Radiological Health. The policy will call for the device center's Office of Device Evaluation to complete within 30 days its review of 510(k)s submitted for changes made to devices as a result of a product recall, according to FDAers. The submissions currently are placed in the normal review queue.
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