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FDA Finalizes 510(k), PMA, eCopy Guidances

FDA spells out its acceptance policies for 510(k) and PMA submissions, as well as guidelines for submitting electronic copies of submissions. The guidances all aim to make the device review process more efficient and speedy.

FDA kicked off the new year with three final guidance documents that it claims will speed up reviews of 510(k) and PMA submissions.

On Dec. 31, CDRH issued final versions of its “Refuse to Accept Policy for 510(k)s” guidance, “Acceptance and Filing Reviews for Premarket Approval Applications”

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