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CDRH Launches Expedited Access Pathway, Extends To De Novos

The center will accept participation requests for its Expedited Access Program beginning April 15 now that it has finalized guidance on the program. It is intended for devices that treat or diagnosis life-threatening or irreversibly debilitating conditions that address an unmet need. The program is primarily targeted at PMA devices, but those that use the de novo classification route are also eligible for a watered-down version.

Device firms with early development-stage devices heading for either a PMA or de novo regulatory route can request

to participate in FDA's new Expedited Access Program (EAP) for the first time on April 15.

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