The FDA has released final guidance for its Humanitarian Device Exemption (HDE) program, incorporating changes wrought by the 21st Century Cures Act and the FDA Reauthorization Act, both passed in 2017.

The agency said it developed the guidance to clarify current HDE program review practices — including the criteria it considers to determine if a device has demonstrated “probable benefit” — and to address commonly asked questions about HDEs and Humanitarian Use Devices (HUDs).

The FDA made some changes to its draft guidance before releasing the final guidance yesterday. For example, in the section on assessing probable risk and benefit in an HDE application, the agency acknowledges that applicants may have little or no clinical experience with a device before they apply for an exemption.

“The types of evidence that may be used to support approval of an HDE application include investigations using laboratory animals, investigations involving human subjects, nonclinical investigations, and analytical studies for in vitro diagnostics,” the guidance says.

It also addresses post-approval requirements and special considerations for devices marketed under an HDE, and a discussion of what would trigger the agency to suspend or withdraw an HDE.

The 21st Century Cures Act amended 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.

Under the 2017 law, the 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 guidance covers devices that are eligible for review by the Center for Devices and Radiological Health and by the Center for Biologics Evaluation and Research. A link to the entire guidance can be found here.