🏛️ Policy & Regulation
FDA AI Device Guidance Watch
Official⏱ Twice a week, Mondays and Thursdays
FDA guidance drops without warning, and finding it late can cost you a comment window or a product redesign. This watch checks the guidance database and Federal Register and alerts you the week anything touches software as a medical device or AI/ML-enabled devices.
- Suggested cadence
- Twice a week, Mondays and Thursdays
- Typically watches
- FDA guidance database · Federal Register · FDA Digital Health Center updates
- Tags
- fda · medical devices · regulatory · digital health · us
The prompt
I manage regulatory strategy for a digital health company building AI-based diagnostic software on the Class II 510(k) pathway. Alert me to new FDA guidance documents, draft guidances open for comment, and enforcement actions covering software as a medical device or AI/ML-enabled devices. Comment deadlines must be included. Parallel EU MDR updates are a bonus; anything purely about hardware devices or drugs is noise.
This is the whole template — the words the wizard analyzes into sources, filters, and a schedule. You review and edit every step before the watch runs.
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