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Let’s Talk Medtech
Exploring FDA's Stance on LDTs & AI
Dec 12, 2023
Regulatory updates on laboratory-developed tests, artificial intelligence, and software discussed by an attorney. Mintz's role in helping medical device companies navigate FDA regulations, including AI and machine learning-enabled software. Importance of understanding FDA regulations for medical devices and software. Discussion on expectations for FDA's final rule on LDTs & AI. Impact of the EUMDR on companies and confusion surrounding compliance. Concluding thoughts on changing regulatory landscape.
34:59
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Quick takeaways
- FDA increased requirements for clinical trial diversity and cybersecurity for software and connected devices.
- The FDA's proposed regulations to regulate LDTs have faced opposition and may involve court challenges and potential legislative action.
Deep dives
Regulatory Compliance for Medical Device Companies
Benjamin Zagarelli, an attorney at Mintz, provides regulatory compliance counsel to medical device companies. He focuses on pre-market regulatory pathways, FDA meetings and communications, obtaining marketing authorization, and maintaining compliance. He also advises companies on how to design and market devices to stay outside of FDA regulation.
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Discover
highlights
Listen to the best highlights from the podcasts you love and dive into the full episode