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The SEC’s Landmark 2026 Crypto Guidance
- April 24, 2026
- Posted by: rob
- Categories: AI & Technology Law, Financial Regulation
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Bias in AI Medical Devices: FDA Training Data Requirements and Product Liability Implications
Only 3.6% of FDA-cleared AI medical devices reported race or ethnicity data from their validation cohort. This post examines what FDA now requires for training data representativeness, and the product liability exposure manufacturers face when demographic bias causes patient harm.
September 21, 2026 Read more -
AI in Drug Development: FDA’s Draft Guidance and What Pharma Companies Must Do Now
FDA’s January 2025 draft guidance on AI in drug development establishes a seven-step credibility assessment framework that pharma and biotech companies must apply to any AI used to support regulatory submissions. Here is what the context-of-use framework requires and what companies must do now.
September 20, 2026 Read more -
Predetermined Change Control Plans: How to Update AI Medical Devices Without a New FDA Submission
The PCCP framework lets AI medical device manufacturers pre-authorize future algorithm updates without filing a new FDA submission for each change. Here is how the three required components work and why building your PCCP at submission time is a strategic necessity.
September 19, 2026 Read more -
FDA Regulation of AI as a Medical Device: SaMD, CDS, and the Classification Decision
Whether your AI healthcare product is a regulated medical device under FDA rules is the most consequential classification decision you will make. Here is how the four-factor CDS test works, what falls inside regulation, and why getting this right at the start matters.
September 18, 2026 Read more