Rick Schrenker
What they argued
RecovryAI’s one-line reading of the filing.
Insists on formal requirements, verification and definitive validation for any device; 'unconstrained generative AI' risks grievous harm.
Themes it raises
1 of the 21 themes in the docket, each with the passage we counted, verbatim.
How this fits rules that already existFDA Q8, Q9, Q16, Q25
“No medical device should be cleared for marketing without following Good Practices already in place including but not limited to establishing formal requirements and specifications as well as verification and and formal and definitive validation tests and procedures.”
Read and coded by RecovryAI readers, September 12, 2026. The source text and highlighted passages appear below. Read the filing on regulations.gov ↗
The comment as filed
Comment submitted on regulations.gov. Passages we counted are highlighted.
No medical device should be cleared for marketing without following Good Practices already in place including but not limited to establishing formal requirements and specifications as well as verification and and formal and definitive validation tests and procedures.
Or if you don’t feel like requiring that, I just want to state for the record that uncomnstrained generative AI will place patients at risk of grievous harm.