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

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

As FDA moves to establish an accelerated development program for breakthrough devices, it is getting diverging input on how expansive the program should be. Industry insists that the agency is thinking too small, while others say FDA must take care to ensure the program is limited and tightly controlled.

CDRH issued a draft guidance

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