FDA Clarifies Post-Cures Act Humanitarian Device Exemptions

As mandated in the 21st Century Cures Act, the FDA issued draft guidance to clarify the agency’s rules on humanitarian device exemptions under the act.

The FDA said it will consider the target patient population, size, intended use and current treatment options in assessing devices for the HDE program.

To qualify for the program, devices should be intended for treatment or diagnosis of conditions affecting a maximum of the Cures Act’s limit of 8,000 U.S. patients. The guidance also explains distinctions between the FDA’s review of HDE applications and the premarket approval application program.