Medical devices set to join the accelerated review club


The FDA proposes an "Expedited Access PMA" (EAP) process for medical devices that treat or diagnose patients with serious conditions whose medical needs are unmet by current technology. The program features earlier and more interactive participation by agency staff to collaboratively develop a plan for the collection of the scientific and clinical data to support approval. The EAP aims to reduce certain devices' development times in addition to the expected shortened premarket review.

Eligible devices must fit the following profile: 1) be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition and 2) represent one of the following: no approved alternative treatment/diagnostic exists or it represents a breakthrough technology that provides a clinically meaningful advantage over existing technology or offers a significant clinically meaningful advantage over currently-available alternatives or the device's availability is in the patient's best interest.

The proposed EAP builds on the Expedited Access Program for pharmaceuticals that the FDA launched in 2011.

Draft guidance

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