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Everyone is aware that ISO 14971 is the gold standard for risk management of medical devices. As the regulatory landscape evolves to forge a path for innovative technology like AI/ML devices, it begs the question of how to apply our existing systems and methodologies to novel technology that is inevitably the future of healthcare.
A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in terms of safety, purity, and potency from an existing approved Biologic on the market.
Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented opportunities to improve patient outcomes, streamline processes, and enhance diagnostic accuracy. As AI and ML continue to make significant strides in the medical field, the U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating these innovations. In this blog post, we'll explore the intersection of AI/ML and medical devices, and how the FDA is navigating this rapidly evolving landscape.
The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for medical device manufacturers. Biocompatibility testing has been a long-standing requirement for a majority of device manufacturers, so this update that includes some excluded materials and devices is a welcome change.
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