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FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain?

This article was originally published in The Gray Sheet

Executive Summary

Companies want FDA to expand the bounds of its accelerated device development program, while others urge FDA to be cautious.

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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.

CDRH Device Expedited Access Program Set For April 15 Launch, Extended To De Novos

The program primarily targets PMA devices, but those that use the de novo classification route are also eligible for a watered-down version for the program. 510(k)s are not eligible for the program.

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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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