The FDA is amending regulations related to its humanitarian device exemptions to reflect changes brought about by the 21st Century Cares Act, according to a RAPS report.
The changes will allow device makers a pathway to develop medical devices designed to treat issues with limited patient populations by exempting them from demonstrating the device’s effectiveness, only requiring them to demonstrate safety from unreasonable risk of illness or injury, according to the report.
The FDA will still restrict manufacturers from selling most HUDs at a profit and will limit their use to facilities with institutional review board oversight, RAPS said.
The patient population threshold will be shifted from its previous state of “fewer than 4,000” to “not more than 8,000,” according to the report. The changes are set to be published in a final ruleset in the Federal Register today.
The federal agency will also amend requirements for IRB oversight which previously required that the IRB overseeing their use be local, according to RAPS.