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FDA Broadens Rules on Humanitarian Device Exemptions to Reflect Cures Act

June 16, 2017

The FDA updated its regulations on humanitarian device exemptions (HDEs) to reflect the 21st Century Cures Act.

Devices covered under the HDE program are intended for small patient populations, but the Cures Act doubled the threshold, broadening its use in populations involving “fewer than 4,000” to “not more than 8,000.”

Under the program, makers of humanitarian use devices (HUDs) may apply for an exemption from the requirement that they prove the device’s effectiveness if they can prove it will not put patients at risk of illness or injury.

The agency also updated regulations for oversight of HUDs to eliminate the requirement that the institutional review board overseeing the devices be local.

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