Pivoting with same indications can be done, but I agree, if you have a Class II or god forbid Class III device, and you change your indications, you've got to redo much of your 21CFR11 documentation. I built a Class I device that eventually became a Class II device, and it was a tough slog to get the QSR and CFR docs in order, however, we were a team of 15, with not nearly $400m in funding.

There is an air on incompetence about this whole thing, and Holmes isn't doing herself any favors battling with poor evidence against WSJ in public.