In February 2026 the Food and Drug Administration (FDA) rolled out Compliance Program 7382.850, and it changed how investigators plan and run a device inspection. Instead of a generic topic list, they now evaluate your quality management system through six QMS areas and four Other Applicable FDA Requirements (OAFRs), choosing what to examine based on the product risks they identify before and during the visit. A ready control room and a runner no longer cover you.

This checklist walks your team through every area an investigator can open, from management oversight and design controls to medical device reporting, corrections and removals, and unique device identification, plus the focus areas the new program weights more heavily, including cybersecurity and prior FDA-483 history. Each item maps to the clause and CFR reference behind it, so you can find and close gaps before they surface during the inspection.