CDRH develops draft guidance for two device-exemption types

08/20/2008 | FDAnews

The FDA's Center for Devices and Radiological Health has released a draft guidance aimed at helping researchers, institutional review boards and device-trial sponsors distinguish between humanitarian device exemptions and investigational device exemptions. With an HDE, manufacturers are not required to provide a reasonable proof of effectiveness. An exemption for an IDE indicates that some rules do not have to be followed to perform a clinical study of an unapproved product, according to the guidance.

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