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report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.
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A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some manufacturers.
FDA device center director Jeff Shuren told Medtech Insight he anticipates MDUFA V negotiation minutes that have not been published in four months will be available imminently.
The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.