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report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.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A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some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.
Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.