martes, 6 de junio de 2017

CDRH Announces Change in IRB Oversight of Medical Device Clinical Trials

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.
Today’s Federal Register announces a technical amendment to 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. The FDA and IRBs continue to employ the same measures and policies to protect patients who are involved in clinical research or are treated with HDE devices. For additional information, contact

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