Not admitted · Vague or promotional
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 23 Nov 2024 · owen-1341
Quote
Vague or promotional
“It will improve the quality of submissions to the FDA and teach medical device manufacturers, many of whom are from outside traditional biosciences, to submit better applications to your agency, which speeds up everything later.”
Letter to Dr. Makary, same 513(g) recommendation: predicted downstream effect on device submission quality and review speed.
No entity, observable event, benchmark or threshold can be written from the text and its immediate context. Slogans ('game changer', 'once-in-a-lifetime opportunity', 'favourite stock') and quantifiers with no countable set ('more', 'first', 'all') without a defined set.