The rules we publish under.
Our readers act on what we send — that is the point of the product, and it is also the liability. These are the standards that govern every item, and where a rule is enforced by the database rather than by promise, we say so.
Sourced, or it doesn’t render
Every item links to the primary FDA document. A dead source link is treated as a defect in the product, not a cosmetic issue. This audience checks — and should.
A bright line between fact and judgment
Every field you read has one of three provenances, and they are visually distinct, always:
- Source — K-numbers, dates, firms, CFR citations. Mechanical, from FDA, no judgment applied.
- Model-drafted, human-approved — the plain-English summary of what changed. AI drafts it; a person approves or rewrites it before you see it.
- Human — urgency and the recommended action. Never model-assigned. This is not policy we remember to follow: the database contains a constraint that refuses to publish an item without a human-written urgency, recommendation, and reviewer name attached.
Why urgency is human
Urgency is the field that fires alerts. A model that cries Critical twice destroys the only asset this product has — your trust that a red item is genuinely red. So a regulatory professional assigns it, for every item, with their name recorded.
Say when it’s unknown
“FDA has not clarified whether this applies to legacy devices” is the most valuable sentence we can send. We never manufacture a takeaway to fill a card, and our classifier is instructed to report its own uncertainty rather than paper over it.
Corrections are appended, never disappeared
If we recommended wrongly, the item says so — dated, above the fold, permanently. The corrections table is append-only and renders on the item’s public page. In a regulated field this is the whole of our credibility.
Relevance over completeness
Being comprehensive is FDA’s job, and FDA does it better. Ten items a week you actually read beat four hundred you filter. We publish what we monitor and what we deliberately don’t.
Silence is a claim
A quiet week renders as “nothing material changed for your products” with the count of documents we read to conclude that— never as an empty screen. We distinguish three states that look identical and mean opposite things: we checked and found nothing (a finding), we haven’t reviewed yet (not a finding), and the system is unreachable (an outage). Only the first earns the quiet sentence.
Not advice
FDA Radar is regulatory intelligence, not regulatory advice. Recommended actions are a starting point written by a professional, not a substitute for your own regulatory judgment on your own facts. When something is consequential enough to need dedicated counsel, the recommendation says that too.