Can an IVD device qualify for HUD designation if the affected patient population is fewer than 4,000 per year but each patient may need to be tested multiple times?
IVD devices qualify for an HUD designation when the number of persons tested with the device is fewer than 4,000 per year. FDA recognizes that the number of tests with the device may exceed one per patient. A device that involves multiple patient uses may still qualify for HUD designation as long as the IVD device is designed for diagnosis or treatment of a total of fewer than 4,000 patients per year in the US. If a device is being developed to diagnose or to help diagnose a disease or condition with an incidence of fewer than 4,000 patients per year, but there are more than 4,000 patients a year “at risk” who would be subject to testing using the device, then the device may not qualify as a HUD. 21 CFR 814.102(a)(5). • Is there a regulation that specifically addresses labeling of IVD products? Yes. The regulation, “Labeling for in vitro diagnostic products,” (21 CFR 809.10), specifies the information required on labeling and in package inserts of marketed products as well as products
Related Questions
- Can an IVD device qualify for HUD designation if the affected patient population is fewer than 4,000 per year but each patient may need to be tested multiple times?
- Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)?
- Is the sight of the patient wearing the device more acceptable for him and his immediate family ?
