Expedited Access for Premarket Approval Medical Devices: A Tortoise? Or a Hare?

The FDA's recently released draft guidance discusses a more collaborative approach for expedited access for pre-market approval medical devices. The Expedited Access Premarket Approval ("EAP") program is intended to help patients gain more timely access to life-saving devices. As with the current expedited access procedure, expedited access status must be requested by the sponsor and agreed to by the FDA.

Click here to read more about what FDA is proposing for EAP, our perspectives on the guidance and how the potential outcomes may affect the pathway from testing to approval.

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