FDA draft guidance to distinguish between device exemptions
An HDE approval is based on safety and probable benefit, and makers of humanitarian use devices (HUDs) are exempt from the requirement to provide a reasonable assurance of effectiveness and may be exempt from certain statutes and regulations when legally marketing the device, according to the draft.
An IDE exemption, however, means that certain statutes and regulations need not be followed to conduct a clinical trial of an unapproved or uncleared device. It also may refer to trials of an approved or cleared device for an unapproved or uncleared indication, the agency noted.
When they initially review an application to conduct an IDE study, the CDRH said that “most IRBs will not know whether the device is a HUD because the IRB review and approval is for an IDE device being used in a clinical investigation.”
The HDE holder is responsible for ensuring that the HUD is used only in facilities with properly constituted and functioning IRBs. The healthcare provider at such facilities is responsible for obtaining IRB approval before the device is used, except in emergencies where the physician in charge determines there isn’t time to get prior IRB approval. In such cases, the physician must report the emergency use within five days and provide written notification to the head of the IRB, identifying the patient involved, the date of the use and the reason.
The FDA has recommended that IRBs reviewing HUD studies use an expedited procedure because a HUD is a legally marketed device and no safety and effectiveness information is being collected systematically as is required for a research protocol.