The US Food and Drug Administration has released a new set of recommendations intended to help eligible manufacturers use the Voluntary Malfunction Summary Reporting (VMSR) program to notify the agency about device malfunctions.
FDA Draft Guidance Clarifies Rules Of Summary Reporting Program
The program allows manufacturers of most lower-risk devices to submit reports of known adverse events via quarterly summaries, rather than individually.
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Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.
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