510(k) Submission Consistency Review demo
Regulatory affairs sees where a 510(k) disagrees with itself, such as a shelf life the data cannot back, written up the way FDA would before it is sent. 1:26
What the demo shows
A 510(k) consistency review: every repeated fact in an eSTAR checked against its sources
Seven agents read eSTAR draft 7 of a powered stapler 510(k) (22 sections, 46 attachments, 1,860 pages) and five records behind it (2,202 pages in all), find 386 facts stated more than once in 914 places, and compare every place with every other. 14 disagree; each becomes a numbered deficiency, citing both places. The regulatory affairs specialist rules which place is right, the owner corrects the source, the agents re-read every place, and a different person accepts. The manager signs the consistency report at zero open, after opening his own sample.
Transcript
- 510(k) Submission Consistency Review reads a draft eSTAR as FDA would.
- For regulatory teams: one FDA request for more information stops the whole review.
- Seven agents read 2,202 pages: fourteen of 386 repeated facts disagree.
- Number six: the sterility section says ethylene oxide; the label, irradiation.
- Sabeline opens the label, then the validation report: it says ethylene oxide.
- She rules with her own password; the fix goes to labeling.
- Delphy, the labeling specialist, opens the label as herself and signs the correction.
- The agents re-read all six places: they agree.
- Sabeline opens the corrected label herself and accepts. Number six strikes through.
- Fourteen found before sending; the manager signs only at zero.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.