FDA Sends Device Remanufacturing Draft Guide To WH For Review

By Beth Wang / May 27, 2021 at 2:17 PM
The White House is reviewing an FDA draft guidance that device makers hope will lay out strict requirements for third-party device servicers. FDA sent the draft guidance, “Remanufacturing of Medical Devices,” to the White House Office of Management and Budget Wednesday (May 26).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. Original device makers have been pushing for strict regulation of independent servicing organizations, which are not regulated by FDA, for years. In January, the Medical Imaging...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.