The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.
The updated implementation guideline developed by GS1 Healthcare US includes instructions for meeting some requirements of the FDA UDI Rule.
The FDA has released a final guidance document regarding the benefits, risks, planning, and implementation of adaptive clinical study designs used in medical device development. These study designs—which can change as the data rolls in—can be more efficient than traditional, fixed clinical designs, can provide more responsive treatment for enrolled patients, and can better protect the welfare of the test subjects, according to the guidance document.
