Twin Cites Chapter: Modifications 510(k): Deciding When to Submit for a Change to an Existing Device

St. Cloud State University at Plymouth

9750 Rockford Rd

Plymouth, Minnesota, USA, 55442-2893

Advanced therapies/cell and gene therapyAPIsBiologics/ biosimilars/ vaccinesBiotechnologyCombination products/companion diagnosticsCosmeticsDiagnostics/IVDsDigital health/SaMD/AIGenericsMedical DevicesNutritional/Natural HealthOTCOtherPharmaceuticals