August 2026 – Digital Health Consult

Highest Impact Request for Comments of the Year — FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

Wow…this may be the biggest drop in regulatory arena this year, as the FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices. I strongly encourage anyone in the FDA regulated device space currently, considering…Read More

August 10, 2026

Do your wellness products meet the FDA requirements for enforcement discretion or are they FDA regulated?

I learned a long time ago to keep tabs on FDA import alerts, which names firms that have been deemed by FDA to be violative of import requirements for a whole host of reasons. Once on the list,…Read More

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Month: August 2026

Highest Impact Request for Comments of the Year — FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

Do your wellness products meet the FDA requirements for enforcement discretion or are they FDA regulated?

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