About the data

ClearanceBrief reads three public FDA datasets through openFDA every night: 510(k) premarket notification decisions, medical device recalls, and the product classification list (used only for product code names).

What counts as new

An item is new on the day it first appears in our copy of the data. Daily emails only include items that are new since your last email and recent: clearances decided in the last 60 days and recalls dated in the last 180 days, so a late data fix never floods your inbox.

Recall to clearance links

When an FDA recall record lists 510(k) numbers, we link the recall to those clearances. We don't infer predicate chains or similarity.

Limits

FDA data can be late, corrected or incomplete. Recall dates use the posting date, or the initiation date when no posting date exists. Always check the official FDA record before acting.

Contact

Questions, wrong codes or data you think is off? Write to Andrew at andrew@clearancebrief.com.

ClearanceBrief is not affiliated with or endorsed by the U.S. Food and Drug Administration.