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US FDA Ready To Accept 510(k) Devices To Expedited Access/Breakthrough Pathway

 
• By Elizabeth Orr

Manufacturers considering the Expedited Access Pathway for 510(k) devices should start the submission process, experts and agency staff say, although it still remains to be seen what types of 510(k) devices will qualify. The December-enacted 21st Century Cures Act added 510(k) devices to the program as part of its Breakthrough Device provision.

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FDA is ready to implement a clause in the 21st Century Cures Act that requires the agency to accept 510(k) devices into the Expedited Access Pathway (EAP) for breakthrough devices, agency staff says. What types of 510(k) devices might qualify for the program in practice remains to be seen, but experts suggest devices that offer significant benefits to patients, even if not completely new, may be the most likely participants.

Introduced by FDA in 2015, EAP offers a faster development path to market for some devices that significantly improve treatment for an unaddressed debilitating or life-threatening disease or condition. The Cures Act, enacted last December, establishes the Breakthrough Devices Pathway, essentially putting the EAP program into statute, and expanding the PMA- and de novo-limited program to include eligibility for 510(k)s devices

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