To employ an accredited person in lieu of an FDA inspection, an establishment must meet certain conditions: - the most recent inspection must have been classified as “no action indicated” or “voluntary action indicated.”
- the establishment must notify FDA of the person it intends to use, and FDA must agree to the selection.
- the establishment must market a device in the United States and must market a device “in one or more foreign countries.”
- the accredited person must be certified, accredited, or otherwise recognized by one of the countries in which the device is to be marketed.
- the establishment must submit a statement that one of the countries in which the device is to be marketed “recognizes an inspection of the establishment by [FDA].”
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