Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41j
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41J
Character Range: 779155–779804

41J  What this Part is about

      The Secretary may seek information or documents relating to:
         • the application of conformity assessment procedures or requirements comparable to those procedures;
         • compliance with the essential principles;
         • compliance with other requirements;
         • distribution of, and other matters relating to, medical devices covered by exemptions under Part 4‑6A or Part 4‑7.
Note: There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.

Division 1—Information relating to compliance with requirements and other matters