The 21st Century Cures Act aimed – among other things – to amend the Federal Food, Drug, and Cosmetic Act to more closely align device and drug regulations. FDA is updating regulations to reflect some of the 6-month-old law’s changes. Details can be found in today’s Federal Register.
Specifically, the 21st Century Cures Act amended Humanitarian Device Exemption (HDE) approval for devices that, among other things, treat or diagnose a disease or condition that affects “not more than 8,000” individuals in the United States. This threshold had previously been “fewer than 4,000” individuals in the United States.
FDA also removed the requirement for local Institutional Review Board (IRB) review for Investigational Device Exemption (IDE) studies and for the use of 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.
The amendments were issued as a final rule, to be effective upon publication. The agency stated that a delayed effective date is unnecessary in this case because the new requirements are already effective as a matter of law. Furthermore, it noted the rule does not establish additional regulatory obligations or impose an additional burden on regulated entities.
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