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FDA Draft Guidance Clarifies Rules Of Summary Reporting Program

 
• By Elizabeth Orr

The program allows manufacturers of most lower-risk devices to submit reports of known adverse events via quarterly summaries, rather than individually.

Digital representation of a networked server room.
• Source: Shutterstock

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.

The agency says that the 9 December draft guidance document “is intended to further explain, but not change” VMSR...

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FDA’s New Menstrual Products Guidance Focuses On Product Risks

 
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With QMSR Nigh, FDA Drops Guidance To Help Industry Prep For New Regs

 
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Can Chatbots Treat Depression? FDA Advisers Urge Caution on Generative AI Tools

 
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FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.

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Can Chatbots Treat Depression? FDA Advisers Urge Caution on Generative AI Tools

 
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Smaller Companies Next Frontier for FDA’s Voluntary Improvement Program

 
• By Elizabeth Orr

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