Notified Bodies Group: New Euro AI Regs Could Cause Undue Burdens
The European medical devices notified bodies association says a proposed rule published earlier in the year risks forcing manufacturers, regulators and notified bodies to duplicate their work.
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Digital Health Roundup: Digital Therapeutics Push Ahead On Standards, Coverage; FDA’s Software Guidance
In this roundup feature focusing on developments in digital health, we highlight the key news and announcements from October.
The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.
The agency published minutes from three MDUFA V user fee meetings with medtech industry. The talks include conversations about carryover funds and filling FTEs from past user fee deals.