Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:2_8
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 2 cl 8
Character Range: 78679–80006

8              United States                                                                                              a MDSAP certificate                                                                                                                                                                                                                   either of the following:
               Food and Drug Administration                                                                                                                                                                                                                                                                                                                        1.      a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or
                                                                                                                                                                                                                                                                                                                                                                   2.     an order approving an application for premarket approval under section 515 of the US FDC Act