MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance
Executive Summary
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report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.
You may also be interested in...
FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says
A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some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.
US FDA’s Shuren Promises MDUFA Update ‘Relatively Soon’
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.
Massive Family Dollar Rat Infestation Leads To Multi-State Recall
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.