Change in Institutional Review Board Oversight

PUBLISHED: Jun 6, 2017
Source: Food and Drug Administration
Relevant to: Hospital, Behavioral Health

The 21st Century Cures Act became law on December 13, 2016. The Act amends the Food, Drug, and Cosmetic Act (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.”

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.

Follow the link below to the Federal Register notice that announces a technical amendment to the FDA’s regulation of medical devices to align the regulations with the FD&C Act. The technical amendment 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). The changes to the regulation and FD&C Act more closely align the device and drug regulations.

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