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FDA's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases

[+] Author and Article Information
Gumei Liu

Office of Orphan Products Development, Office of Special Medical Programs, US Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993
gumei.liu@fda.hhs.gov

Eric Chen

Office of Orphan Products Development, Office of Special Medical Programs, US Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993
eric.chen@fda.hhs.gov

Debra Lewis

Office of Orphan Products Development, Office of Special Medical Programs, US Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993
debra.lewis@fda.hhs.gov

Gayatri Rao

Office of Orphan Products Development, Office of Special Medical Programs, US Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993
gayatri.rao@fda.hhs.gov

1Corresponding author.

ASME doi:10.1115/1.4036333 History: Received October 30, 2016; Revised February 26, 2017

Abstract

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. Analyses of HDE approvals from 2007-2015 revealed that approvals were based on a broad range of data constituting valid scientific evidence to support a finding of safety and probable benefit and demonstrated that the FDA exercises a high degree of flexibility when reviewing HDE applications.

Section 4: U. S. Gov Employees
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