NEW YORK — The US Food and Drug Administration today issued a final guidance to provide updated information about the application process for its Humanitarian Device Exemption (HDE) Program, firming up a draft guidance for this regulatory pathway issued in June 2018.
An HDE application is a premarket submission for a Humanitarian Use Device, or HUD, employed in the treatment or diagnosis of rare diseases or conditions that affect up to 8,000 people in the US each year. A device approved under an HDE application is exempt from the requirement to demonstrate a reasonable assurance of effectiveness.
For a device to be eligible for an HDE, the FDA must determine that the device would not be available to a person with a given disease or condition without the HDE approval. Further, the agency must establish that there is no comparable device available to treat or diagnose the disease or condition, other than another device approved under an HDE or IDE.
The FDA said that its final guidance explains the principal criteria it considers when determining whether probable health benefits have been demonstrated for a device being reviewed through the HDE program.
The final guidance also describes the FDA's assessment of the probable benefits and risks for a device. The agency said that when it conducts a probable benefit-risk assessment, it considers relevant factors in the context of the intended use of a device, including the target patient population and the size of the population. Further, the FDA's probable benefit-risk assessment considers alternative treatments or diagnostic tests that are commercially available.