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FDA Draft Guidance Clarifies Rules Of Summary Reporting Program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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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.
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Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.
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Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.
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Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.
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Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.
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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.