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PCCP concept at risk of being subsumed in debate over artificial intelligence

The U.S. FDAโ€™s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in othe...
Predetermined Change Control Plan

AdvaMed Launches New Digital Health Tech Division, Appoints Board Members

AdvaMed, the Medtech Association, announced the formation of AdvaMed Digital Health Tech, a new division within the organization that represents digital medical technology companies and promotes the critical role of data and digital medtech in transforming health care. The group, which is led by Shaye Mandle, acts as a thought leader and convener for the industry and focuses on four core policy areas: regulation, payment and health care delivery, data stewardship and privacy, and cybersecu...
United States Robert Cohen Sumbul Desai David Rhew Urvashi Tyagi Shaye Mandle

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Advanced Medical Technology Association Updates Ethics Policies

The Advanced Medical Technology Associationโ€™s AdvaMed Board of Directors approved updates to the AdvaMed Code of Ethics, which provides guidance to the healthcare industry on interactions between medical technology companies and healthcare professionals HCPs.
Technology Association Advamed Board Of Directors Advanced Medical Technology Association Advamed Code Advanced Medical Technology Association Dvamed Code Of Ethics Healthcare Ethics

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