Joel Grunhut

Public / patientsMember of the publicFiled September 7, 202611,636 words · 1 attachmentFDA-2026-N-7874-0073

What they argued

RecovryAI’s one-line reading of the filing.

Attachment is the FDA discussion paper text itself; no commentary visible in the record.

FDA questions it names

Questions this filing names by number.

Q1 · The two-axis risk framework Q2 · The spectrum of device activity Q3 · When an output becomes directive Q4 · Generalist and specialist users Q5 · Multi-turn conversations that migrate Q6 · Care escalation functions Q7 · The competency-based approach Q9 · The benchmarking structure Q10 · Benchmark contamination and saturation Q11 · Clinical confirmation without a prospective trial Q12 · Statistically meaningful performance Q13 · Synthetic data Q14 · Comparators and acceptance criteria Q15 · Performance against usual care Q16 · Independent third parties Q17 · Devices with many functions Q18 · Trading premarket certainty for postmarket monitoring Q19 · Postmarket performance evaluation Q20 · Machine-based supervisory agents Q21 · Clinicians, institutions and societies Q22 · Re-benchmarking after a modification Q23 · PCCPs for GenAI devices Q25 · Foundation Model Master Files Q26 · Agentic devices

Read and coded by RecovryAI readers, September 12, 2026. The original submission is linked below. Read the filing on regulations.gov ↗

This filing was submitted by a member of the public. We publish our analysis here and link to the submission rather than reproducing it, and this page is not indexed by search engines. Read the full submission on regulations.gov ↗

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