Monitoring FDA every business day

Know what changed.
Know what to do next.

FDA regulatory intelligence for medical device manufacturers. We read every guidance, warning letter, classification change and Class I recall — then a regulatory professional tells you which ones touch your device, and what to do about it.

The arithmetic

Most of it isn’t about you. Finding the part that is, is the job.

Doing this yourself means reading the Federal Register before your first meeting, every morning, forever. Not doing it means finding out in a quarter — from a customer, an auditor, or a competitor’s clearance.

507FDA documents published

Federal Register, warning letters, recalls, clearances — 30 days, measured.

77worth a human's attention

The rest is routine Class II recalls and clearances. Searchable, never pushed at you.

?touch your device

We can’t know that number without knowing your device — and nobody who quotes you one can either. Finding it, every week, is the entire job.

What arrives

One email. What changed, and what each one means for you.

CRITICALClassification Change2026-06-26

Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant

FDA issued a final order classifying the foam or gel chemical sterilant/high level disinfectant into Class II with special controls. The special controls identified in the order become part of the codified classification language.

Recommended action · written by a person

If you market a foam or gel sterilant, your next 510(k) must cite these special controls. Pull your existing test protocol and check it against the codified list before you submit — the ones added here are not in the old guidance.

Read the FDA source →

What changed
Plain English. Not what the document is about — what is different now that wasn't yesterday.
Who it touches
The specific class of manufacturer affected, not “device companies should be aware”.
The recommended action
Written by a regulatory professional, naming the artefact to change: the section, the SOP, the test report.
The primary source
Every item links to the FDA document itself. Never to someone else's summary.

How it works

A machine reads everything. A person decides what it means.

Monitor

Every business day we pull the Federal Register, CDRH warning letters, device recall enforcement, and 510(k) clearances straight from FDA's own APIs.

Draft

AI reads each document and writes a factual summary of what changed. It never assigns urgency and it never recommends an action — it isn't allowed to.

Review

A regulatory professional sets the urgency and writes the recommendation. Nothing reaches you unreviewed — the database physically rejects it.

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.

Coverage

Straight from FDA. Never from someone else’s summary.

FDA guidance documents

Announced in the Federal Register. Draft and final.

LIVE

Classification changes

New device types and reclassifications, with special controls.

LIVE

Final & proposed rules

Including comment deadlines, so you can still respond.

LIVE

Warning letters (CDRH)

Company, date, and the violation themes that are trending.

LIVE

Class I recalls

The ones FDA reserves for probable serious injury or death.

LIVE

510(k) clearances

Searchable — including who cleared against your predicate.

LIVE

Recognised consensus standards

When FDA recognises an edition — and when the old one sunsets.

SOON

EU MDR

For manufacturers carrying both markets.

SOON

Boundaries

What it isn’t.

A regulatory professional discounts anything that won’t draw its own boundary. So here is ours.

Not a news feed

If you could have read the source in the same time, the item has no reason to exist.

Not a GPT wrapper

The model summarises. It is structurally forbidden from setting urgency or recommending anything.

Not an enterprise contract

No demo gate, no annual commit, no sales engineer. You can just read it.

Not regulatory advice

It is regulatory intelligence, written by regulatory people. Your submission is still yours.

Open it before your email.

One email a week. Everything that changed, what it means, and what to do — or a short note saying nothing material changed, which is worth knowing too.