The FDA released new draft guidance detailing the submission process for products seeking humanitarian use device designation for the U.S. market.
The document aims to define expectations for med-tech manufacturers as well as FDA reviewers considering HUD applications. HUD designation is the first step to market clearance under a humanitarian device exemption.
The humanitarian use device program, run by the agency’s Office of Orphan Products Development, applies to devices that diagnose or treat diseases and conditions affecting fewer than 4,000 people in the U.S. per year.
Humanitarian device exemption applications are similar to pre-market applications in that both require certain standards of safety, but effectiveness standards are more lax for HDE applications. Obtaining designation as a humanitarian use device is necessary for winning HDE clearance for the U.S. market, but it’s not a guarantee.
The draft guidance details how a manufacturer might define a patient population, demonstrate that the device works for that population and how the demonstration varies depending on whether the device is meant for diagnosis or treatment.
The watchdog agency is accepting comments on the proposed guidance until March 12, 2012.