Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)?

April 26, 2017Approval device hde HUD Humanitarian IVD Marketing

0

Posted

Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)?

1 Answer

0

Posted

Yes, it is possible for an IVD device to be approved for marketing under the HDE. See the Glossary for definitions, 21 CFR 814 Subpart H, and Appendix 1 for more information.