Certifications FDI currently holds the following domestic and international certifications: FDA 21 CFR 820, 801, 803, 806, and 807 ISO 13485:2016 Medical Device Quality System ANSI/AAMI ST8, ST55 ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 ASME Boiler and Pressure Vessel Code Section VIII, Division 1 State of Tennessee Occupational Safety and Health Administration
