CDRH Topsiders Focus On Use Of Standards In 510(k)s, Look To Poll Industry
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Devices and Radiological Health is looking to standardize its approach to special controls guidance documents, according to staffers
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Abbreviated 510(k) Template May Spark Broader Use Of Program
CDRH's Office of Device Evaluation is looking to collaborate with device manufacturers to develop summary reports for abbreviated 510(k)s