AdvaMed Takes Issue With FDA Guidance on Humanitarian Device Exemption

AdvaMed said it strongly supports the FDA’s efforts to provide clarity around “probable benefits” from marketing authorizations for humanitarian use devices, but the association said the guidance needs to make it clear that randomized clinical trials are not needed to demonstrate probable benefit.

This is especially true for pediatric populations where randomization can be ethically challenging, AdvaMed said.

The FDA issued draft guidance to clarify the agency’s rules on humanitarian device exemptions under the 21st Century Cures Act. The agency said it would consider the target patient population, size, intended use and current treatment options in assessing devices for the HDE program.