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CDRH's Expedited Access Pathway: 17 Devices And Counting

A system using nerve stimulation to treat diaphragm atrophy in mechanical ventilation patients is the latest product to be granted EAP designation. FDA officials recently confirmed that 17 devices have been accepted to the expedited development pathway about a year after the program launched.

Lungpacer Medical Inc. is the most recent company to be accepted into FDA’s Expedited Access Pathway (EAP), a year-old program intended to give innovative devices a regulatory leg-up to speed the path to market. The company announced that its Lungpacer Diaphragm Pacing System had been granted an EAP designation on May 11.

“Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most...

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