FDA Sends Device Remanufacturing Draft Guidance to White House for Review

The White House is reviewing an FDA draft guidance that Medical Imaging & Technology Alliance (MITA) officials hope will lay out strict requirements for third-party device servicers.

FDA sent the draft guidance, “Remanufacturing of Medical Devices,” to the White House Office of Management and Budget Wednesday (May 26). The guidance was included on FDA’s fiscal 2021 guidance priorities list.

To see the full article, visit the Inside Health Policy website.