Tag Archives: 510(k)

Artificial Intelligence Graphic

Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz
Artificial Intelligence Graphic

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

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510k Submission Planning

510k Submission Planning

By Joy Greidanus
510k Submission Planning

510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.

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Artificial intelligence, medical devices

The Regulatory Aspects of AI/ML-based SaMD

By Zuhal Reed
Artificial intelligence, medical devices

Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.

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