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

Executive Summary

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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