What Does HDE Stand For?

HDE stands for Humanitarian Use Exemptions CDRH

HDE, or Humanitarian Use Exemptions CDRH, refers to a regulatory pathway established by the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA). This program is designed to facilitate the approval of medical devices intended for the treatment or diagnosis of rare diseases or conditions affecting fewer than 8,000 individuals annually in the United States. By providing a streamlined process, HDE allows developers to bring innovative devices to market more efficiently, addressing unmet medical needs while ensuring patient safety and effective oversight.

Other Meanings for HDE