Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_8
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 8
Character Range: 43601–44816

8          United States                                                            a MDSAP certificate                                                                                                                                                                 for medical devices that are not exempted, by the United States Food and Drug Administration, from section 510(k) requirements—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 granting a request for classification under section 513 of the US FDC Act (a De Novo classification request)