FDA is currently seeking comments on the collection of information regarding the Humanitarian Device Exemption (HDE) applications and related requirements. As summarized by an article in MassDevice, the FDA is interested in learning:
- Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
- The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
- The ways to enhance the quality, utility, and clarity of the information to be collected;
- The ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
When used properly the HDE program can provide an incentive for the development of devices for the treatment or diagnosis of rare diseases or conditions. Typically patients who receive humanitarian device exemption devices have no other comparable device available to diagnose or treat their disease or condition. According to the FDA overview of the HDE program, devices in this category are 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
- Not expose patients to an unreasonable or significant risk of illness or injury
- Benefit patients health while outweighing the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment
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. 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.
In addition, the article points out that “HUD approved devices under an HDE may not bring in revenues in excess of the R&D costs incurred by the issuing company, except some device for use in pediatric patients or in a pediatric subpopulation, according to FDA.”
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