Device Watch

Your regulatory position rests on devices you don't control. The predicate your 510(k) cites, the competitor clearing into your product code, the PMA supplement that quietly changes a rival's design, the recall that touches a device your strategy depends on — all of it is on FDA's public record, and almost nobody watches it continuously below the enterprise price tier.

What one watch monitors (per FDA product code)

510(k) clearances — competitor activity in your code, with the K-numbers each new clearance cites (predicate/reference devices, extracted from the 510(k) summary documents).
PMA originals and supplements — the class-3 lane 510(k) tracking misses; supplements are where design and process changes appear.
Recalls — FDA's public record, cross-referenced: an alert flags when a recalled device is cited as a predicate by recent clearances, or when a recall references a PMA in your watch.
MAUDE report volumes — monthly adverse-event report counts with a conservative anomaly check (complete months only, absolute floor, no alert without history). MAUDE counts are raw report counts, not confirmed failures and not rates — FDA's own caveats apply, and ours repeat them.

How it arrives. A baseline snapshot at activation, then change-only email alerts: no email means no new events. Data refreshes daily from FDA public sources. Coverage is cardiac-first (436 cardiovascular product codes in the tracked classification corpus.)

Pricing

$199/month per watch — one watch covers up to 3 FDA product codes. To activate, email billing@biomedistats.com with the product codes you need watched (self-serve checkout is coming shortly).

Method: deterministic monitoring of FDA's public 510(k), PMA, recall and MAUDE databases. Alerts report the public record; they are not legal or regulatory advice. The monitoring data itself is available to subscribers only.