COVID-19 Shows Remote Monitoring Can Work For Pre-Cert Program
In an update to stakeholders, the US FDA says regulators can successfully evaluate a firm’s performance, allowing it to eventually get medical software to market in the agency’s Pre-Cert Program.
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Bakul Patel, director of the US agency’s new Digital Health Center of Excellence, tells Medtech Insight he’s looking to hire staff that want to shape the digital health regulatory landscape.
The top official on artificial intelligence products at the US FDA says that while the agency has some authorities to implement regulatory oversight, it may need additional powers from Congress considering the direction the FDA may possibly take in regulating AI and machine learning products.
Podcast: US FDA’s Artificial Intelligence Guidance May Need Congress And Is At Least A Year Away, Expert Says
Zach Rothstein, the top artificial intelligence and machine learning lobbyist at device industry advocacy group AdvaMed, wrote to the US FDA with recommendations on how to regulate AI/ML devices. He sat down with Medtech Insight to break down the topic's most important issues.