Recent Posts
On February 2, 2024, we finally got our long awaited Final Rule establishing the new Quality Management System Regulations (QMSR) from the FDA. The new QMSR is essentially the full implementation of ISO 13485 by incorporating the entirety of this standard by reference. With global regulatory frameworks becoming more difficult to manage in terms of compliance, harmonizing with the entirety of the ISO standard with FDA regualtions should have a net positive effect on industry.
Read MoreA recent Northeastern University panel discussion about about the history and future of governance in artificial intelligence got me thinking about harmonization of medical device regulatory policy and wondering why it is so hard to do. As medical device technology is advancing at breakneck speed to bring AI-driven medical devices to patients and practitioners, we are seeing a rapid increase in policy implementation and legislation all intended to govern the use of AI in medical devices - but without much harmonization. Similar lack of harmonization in device classification, quality systems, and RWD/RWE governance have created barriers and costs to industry. With IMDRF being only a voluntary-based collaborative organization, what can be done to facilitate global harmonization of medical device regulation?
Read MoreRegulation of artificial intelligence/machine learning (AI/ML) medical devices is heating up worldwide. While FDA has only issued one guidance document and an action plan, the EU is preparing to enact significant legislation that will govern the regulation of AI, including AI medical devices, in the EU. The EU AI Act is scheduled to go into affect in 2024. Medical Device sponsors with AI/ML devices must be ready to meet the requirements of the AI Act along with EU MDR.
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