According to a news-release on Federal Register, FDA has finalized the draft guidance released in December 2011 under the same title “Humanitarian Use Device (HUD) Designations”. The guidance FDA published is intended to provide further information and assistance to those preparing applications/submissions as well as FDA reviewers when dealing with this special class of devices.
- Demonstrating in HUD designation requests that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year
- How this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes
- How properties of the device may affect this demonstration
- For the purpose of a HUD designation request, delineating a medically plausible subset (“orphan subset”) of persons with a given disease or condition that affects or is manifested in 4,000 individuals or more in the United States per year
The final guidance FDA published includes an HUD decision flow chart which increases transparency of the application and review process. It is noted in the guide that in its review, FDA “identifies the disease or condition that the device treats or diagnoses, evaluates the population estimate, and reviews the scientific rationale for the device.”
According to the FDA overview of the HDE, this means that the device is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer then 4,000 individuals in the US per year. The HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.
Furthermore, An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. Also, these devices cannot expose patients to an unreasonable or significant risk of injury or illness.
In the release of the draft guidance in December 2011, FDA was seeking comments on the collection of information regarding HDE applications and related requirements. Checkout our blog we posted for more information regarding FDA’s collection of comments.
Do you have any experience in the HDE/HUD process? Share your experiences and thoughts on this guidance below!
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