21st Century Cures Act: FDA Amends Certain HDE and IRB Requirements

By MedTech Intelligence Staff

IDE studies no longer have to rely on local IRBs; plus, changes are made to the patient threshold regarding HDE approval.

The Federal Register has announced a technical amendment to the Food, Drug, and Cosmetic (FD&C) Act per the 21st Century Cures Act. The first change is an amendment to the FD&C Act to allow for humanitarian device exemption (HDE) approval for devices that treat or diagnose a disease that affects no more than 8000 people in the United States. The previous patient threshold for HDE approval had been fewer than 4000 people.

The second change is an amendment to the FD&C Act that removes the requirement for local Institutional Review Boards (IRB). As a result, during an Investigational Device Exemption (IDE) study, clinical trial medical device investigators, sponsors and clinical sites can rely on a central IRB instead of a local IRB.

“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,” FDA stated in a release. The changes are effective June 7, 2017.

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