One product in. Its whole FDA landscape out.
Pick a product below and watch what FDA did about it in the last thirty days. These are real items from a live pull — and the reason each one matched is on the card.
- Product code
- FEB
- Regulation
- 21 CFR 876.1500
- Class
- II
- Clearance
- K261880
Real items from a live 30-day pull. Every one reviewed by a regulatory professional before it reaches you.
Your product isn’t a keyword. It’s a set of identifiers.
Alerts are noisy because most tools search words. FDA doesn’t publish in words — it publishes against codes. Your product already has those codes, which is why this is a match and not a search.
…when the notice calls it an “endoscopic light-projecting measuring device”. The identifier doesn’t miss. That is the entire difference between an alert you trust and one you learn to ignore.
Recalls carry no product code — we checked all 300 in the last 30 days. Nobody can join those exactly, whatever they tell you. We match on the device itself and a regulatory professional confirms it before it reaches you. That review is why the imperfect half is still safe.
507 documents a month. Almost none are about your product.
Finding the ones that are means reading the Federal Register before your first meeting, every morning, forever. Not finding them means hearing about it in a quarter — from a customer, an auditor, or a competitor’s clearance.
A machine reads everything. A person decides what it means for you.
A name and whatever identifiers you have — product code, regulation, application number, your firm and your CMO. Thirty seconds. More detail sharpens the match; none of it is required.
The Federal Register, CDRH warning letters, recall enforcement and clearances, straight from FDA's own APIs — matched against your identifiers, not against a keyword.
A regulatory professional sets the urgency and writes the recommendation. The AI drafts the summary and is structurally forbidden from doing either. Nothing reaches you unreviewed.
A generated “review this guidance before your next submission” is worth nothing — anyone can produce it in an afternoon. The reason this exists is the sentence that comes after, and that one is written by someone who has actually filed.
Whatever you make, it’s the same problem.
Straight from FDA’s own APIs and the Federal Register. Never from someone else’s summary — every item links to the primary document.
- Classification orders & special controls
- 510(k), De Novo, PMA clearances
- Class I recalls
- CDRH warning letters
- QSR / 21 CFR 820 changes
- Guidance for industry
- Final & proposed rules
- Labelling & REMS changes
- CDER warning letters
- Comment deadlines
- Guidance for industry
- BLA-relevant notices
- Cell & gene therapy policy
- CBER warning letters
- Advisory committee notices
Device coverage is live today. Drug and biologic sources are being switched on now — add your product and you’ll be watched from the day yours lands.
What it isn’t.
A regulatory professional discounts anything that won’t draw its own boundary. So here is ours.
If you could have read the source in the same time, the item has no reason to exist.
We match the identifiers FDA keys its data on. Words are how the noise gets in.
The model summarises. It is structurally forbidden from setting urgency or recommending anything.
No demo gate, no annual commit, no sales engineer. You can just use it.
What are you monitoring today?
If the answer is a Google Alert and a colleague who forwards things, add your product and let us take it from here.