The FDA this week released new information to accompany humanitarian device exemption applications and related requirements.
The new guidelines build on an announcement the FDA issued last year, detailing the process for classifying a product as a humanitarian use device.
The humanitarian use device program applies to devices that diagnose or treat diseases and conditions affecting fewer than 4,000 people in the U.S. per year.
The program also applies to a device which has no comparable device available to patients, which will not expose an unreasonable or significant risk of illness or injury or the probable benefit to health outweighs the risk of injury or illness from its use, FDA noted.
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.
The watchdog agency is accepting comments on the proposed guidance either online or
mail until February 15, 2013.The topics are as follows:
1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
2. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. The ways to enhance the quality, utility, and clarity of the information to be collected;
4. 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.