What is the purpose of Humanitarian Use Devices as per 21 CFR 814 Subpart H?

The purpose of Humanitarian Use Devices, as outlined in 21 CFR 814 Subpart H, is specifically to address the needs of patients suffering from rare diseases or conditions. These devices are intended to treat or diagnose diseases that affect fewer than 8,000 individuals in the United States per year. This regulatory pathway facilitates the development and approval of devices that may not otherwise be economically viable due to the small patient population, allowing manufacturers to address critical medical needs while adhering to safety and efficacy requirements.

The focus on rare diseases ensures that patients who have limited or no treatment options can access potentially beneficial technologies. This regulatory framework provides a balance between ensuring device safety and efficacy and promoting innovation for underserved populations.