Asked, answered.
Does AI write the recommendations?
No, and this is enforced rather than promised. AI drafts the plain-English summary of what changed; a regulatory professional writes the urgency and the recommended action for every single item, and the database refuses to publish an item without them. The full rules are in our editorial standards.
How does FDA Radar know what affects my product?
By identifiers, not keywords. Your profile holds your product code, CFR regulation, K-number, and firm names; FDA’s own data carries the same identifiers, so matching is a database join. The “why this affects you” line on every match shows the actual key that matched — you never have to trust a black box’s opinion about relevance.
What about recalls, which carry no identifiers?
True, and most tools quietly fail here. FDA publishes no product codes on recall records, so our reviewer — who already reads every Class I recall to assign its urgency — supplies the product code by hand. Matches made that way are labelled as reviewer-keyed, so you can always tell FDA’s data from our judgment.
Do you cover drugs and biologics?
The monitoring today is device-first: guidance, classification changes, CDRH warning letters, device recalls, and 510(k) clearances. You can register drug and biologic products now — profile derivation and firm matching already work for them — and deeper CDER/CBER coverage follows where subscriber portfolios point.
Do you monitor my competitors' submissions?
Pending submissions, no — FDA does not publish them, and any vendor claiming otherwise is describing data that does not publicly exist. Clearances, yes: your product page shows every 510(k) cleared in your product code, as published by FDA.
What does it cost?
Nothing right now — see pricingfor exactly why, and what the paid tier will look like when it exists (self-serve, roughly $99–299/month, no demo gate).
How often will you email me?
Once a week, plus an immediate alert if something Critical touches one of your products. On quiet weeks the email still arrives and says so with evidence — the count of documents we checked — because “we looked and found nothing” is the finding you’re here for.
Is this regulatory advice?
No. It is regulatory intelligence: what changed, why it plausibly matters to you, and a professionally written starting point for action. Decisions about your submission on your facts remain yours — and where a change is consequential enough to need dedicated help, the recommendation says that plainly.
Who is behind this?
Regulatory Leadership Partners — see about. The review discipline exists because the people reviewing have filed the submissions this product monitors.