Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_11
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 11
Character Range: 63591–64798

11             United States                                                            a MDSAP certificate                                                                                                                                                                                                                  one of the following:
               Food and Drug Administration                                                                                                                                                                                                                                                                                    (a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act;
                                                                                                                                                                                                                                                                                                                               (b) an order approving an application for premarket approval under section 515 of the US FDC Act