Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_10
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 10
Character Range: 52741–54419

10             United States                                                            a MDSAP certificate                                                                                                                                                                                                                   one 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;
                                                                                                                                                                                                                                                                                                                                 2.        an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request); or
                                                                                                                                                                                                                                                                                                                                 3.         an order approving an application for premarket approval under section 515 of the US FDC Act