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FCC TCPA opt-out rule takes effect · Nov 25, 2026 · See what changes

AI Policy Desk

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FDA AI Device Orders Compared: Rules vs. Real Accuracy

·7 min read

FDA AI Device Orders Compared: Rules vs. Real Accuracy

Four FDA orders put algorithm-based devices in class II. I compared what each rule requires with the accuracy the first product in each type showed.

healthcare-aifdamedical-devicesvendor-risk
Clinical AI Decision Support: FDA CDS Guidance Explained

·9 min read

Clinical AI Decision Support: FDA CDS Guidance Explained

Check FDA's four-factor test to see if your clinical AI decision support tool is exempt Non-Device CDS or regulated SaMD under the January 2026 guidance.

healthcare-aifdaclinical-decision-supportcompliance
FDA AI Medical Device Compliance: SaMD, 510(k) and PCCP

·10 min read

FDA AI Medical Device Compliance: SaMD, 510(k) and PCCP

1,350+ AI medical devices are FDA-cleared. Which SaMD class, 510(k) or PMA pathway, and PCCP rules govern your 2026 compliance plan?

fdasamdhealthcare-aimedical-device
Midjourney Body Scanner Claims: What FDA Clearance Requires

·9 min read

Midjourney Body Scanner Claims: What FDA Clearance Requires

One word keeps Midjourney's 60-second scanner out of FDA AI medical device clearance in 2026. Here's what the SaMD pathway actually requires.

healthcare-aifdamedical-deviceai-governance