On Wednesday, June 7th, the FDA amended its final rule concerning humanitarian use devices (HUDs). The amendments to the regulations are being made in response to changes recently enacted into law by the 21st Century Cures Act.
21st Century Cures Act
The 21st Century Cures Act was signed into law on December 13, 2016, modifying certain provisions of the Federal Food, Drug, & Cosmetic (FD&C) Act.
Section 3052 of the 21st Century Cures Act amended section 520(m) of the FD&C Act to “allow for 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 been ‘fewer than 4,000’ individuals in the United States.”
Furthermore, section 520 of the FD&C Act was also altered by section 3056 of the 21st Century Cures Act, stating that institutional review committees, such as IRBs, are no longer required for a device to be considered ‘local’.
FDA Updates Humanitarian Device Exemptions (HDEs)
In order to maintain consistency with the changes enacted by the 21st Century Cures Act, FDA’s “final rule amends part 814 (21 CFR part 814) in several places to accurately reflect the threshold recently enacted into law.” In addition, the Agency’s final rule also “amends 21 CFR 814.124(a), ‘IRB approval’, to remove the term ‘local’ and related language in order to accurately reflect the requirements recently enacted into law.”
In its announcement in the Federal Register, FDA states that this amendment is being issued as a final rule without notice and will take effect immediately. The Agency notes that a delayed effective date is not necessary because the new requirements are a matter of law, and thus already effective.
For additional information on the modifications to the final rule, view FDA’s Federal Register announcement.