Since 2019, manufacturers of medical devices with artificial intelligence and machine learning capabilities have been awaiting official guidance on submitting post-market changes to the US Food and Drug Administration.
Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’
The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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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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Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.
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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.