FDA Implements 21st Century Cures Requirements for Devices

Today’s Federal Register announces a technical amendment to FDA’s regulation of medical devices to align the regulations with the the Food, Drug, and Cosmetic Act (FD&C Act). The 21st Century Cures Act became law on December 13, 2016, and amended the FD&C Act by removing the requirement for local Institutional Review Board (IRB) review for Investigational Device Exemption (IDE) studies and for the use of Humanitarian Device Exemption (HDE) devices by striking the references to the term “local.” Accordingly, the technical amendment to the regulation removes the term “local” from the description of IRB review in the HDE regulation (the term “local” does not appear in the IDE regulations and does not need to be changed).

This means that medical device investigators, sponsors, and clinical sites can choose to rely on a central IRB rather than an institution’s local IRB for these activities. This includes IRB review for multi-site studies. The changes to the regulation and FD&C Act more closely align the device and drug regulations. The FDA regulations regarding IRBs continues to employ the same requirements to protect patients who are involved in clinical research or are treated with HDE devices.

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