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Multiple MDUFA Policies In Transition Phase Until Jan. 1

For now, CDRH remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k) submissions and its mandate for electronic copies of pre-market submissions, each of which have been addressed in recent guidance documents.

CDRH is aiming to implement some key policies associated with the recent FDA user fee reauthorization agreement by the first of next year.

But, for now, the device center remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k)...

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