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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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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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