The Food and Drug Administration's (FDA) Humanitarian Device Exemption (HDE) is a unique marketing approval pathway for medical devices targeting diseases affecting small (rare) patient populations. In an effort to increase the utilization and success of this pathway, the FDA has analyzed data from HDE approvals from 2007 to 2015 to identify factors that have contributed to a successful HDE marketing application. There were 28 HDE approvals during the analysis period and were based on a broad range of data constituting valid scientific evidence. Most had at least one prospectively conducted clinical trial to support safety and probable benefit. An analysis of these HDE approvals demonstrates that the FDA exercises a high degree of flexibility when reviewing HDE applications.
Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
Manuscript received October 30, 2016; final manuscript received February 26, 2017; published online June 27, 2017. Assoc. Editor: Michael Eggen.This material is declared a work of the U.S. Government and is not subject to copyright protection in the United States. Approved for public release; distribution is unlimited.
- Views Icon Views
- Share Icon Share
- Cite Icon Cite
- Search Site
Liu, G., Chen, E., Lewis, D., and Rao, G. (June 27, 2017). "Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases." ASME. J. Med. Devices. September 2017; 11(3): 034701. https://doi.org/10.1115/1.4036333
Download citation file:
- Ris (Zotero)
- Reference Manager