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CDRH Launches Expedited Access Pathway, Extends To De Novos

This article was originally published in The Gray Sheet

Executive Summary

The center will accept participation requests for its Expedited Access Program beginning April 15 now that it has finalized guidance on the program. It is intended for devices that treat or diagnosis life-threatening or irreversibly debilitating conditions that address an unmet need. The program is primarily targeted at PMA devices, but those that use the de novo classification route are also eligible for a watered-down version.

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'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program

The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."

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

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.

Senate Poised To Vote On Cures Bill; Headed To Likely Enactment This Term

Following House passage of a combined House/Senate 21st Century Cures package Nov. 30, the Senate will take up the bill on Dec. 5 or 6, said Senate HELP Committee Chair Lamar Alexander, R-Tenn., who shepherded a similar package of medical innovation bills through the committee earlier this year. While some Democrats remain vocal in opposing the bill based on worries that it will water-down FDA safety protections and funding concerns, the House vote showed lopsided support, and the Senate is expected to pass it and the president to sign.

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