The FDA Reauthorization Act of 2017, FDARA, changed the process for device inspections. The Ombu Library, in the FDA Information aisle, has an article that explains the change.
FDA should provide advance notice of the inspection, provide the establishment with a reasonable estimate of the timeframe, provide an opportunity for advance communications, and provide communications during the inspection about its status. The status communication “may be recorded by either party with advance notice and mutual consent”
In addition, the change requires new guidance documents to implement the provisions described above.
A device is now considered adulterated, just as a drug, if the manufacturer refuses entry or an inspection.