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MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance

Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.

Entrance to FDA headquarters in Maryland

Booz Allen Hamilton (BAH) gave the US Food and Drug Administration a glowing review in a recently published independent report that found the agency has fulfilled almost all its obligations under the Medical Device User Fee Amendments (MDUFA IV) deal. It did, however, find the agency still hasn’t published a long-overdue digital health premarket guidance.

BAH’s independent assessment report that was published 1 October evaluated 12 areas that the FDA and industry had agreed upon five years ago, including streamlining the agency’s premarket review...

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