CDRH Creates an Inspections Database

CDRH announced a database for certain inspections. The inspections in the database are limited to those for which CDRH had direct involvement. In general, FDA’s Office of Regulatory Affairs (ORA) conducts device inspections. CDRH becomes involved in inspections such as foreign inspections, Medical Device Reporting (MDR) malfunction issues, labeling, and software issues.

You can search the Inspection database by Company Name, Country, Medical Specialty, Inspection Type, Product Code, Inspection Classification, Inspection Action, District, or Date. The database has the following URL.