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Humanitarian Device Exemption
open-in-new
<h2 id="requirements">Requirements</h2> <p>To qualify, the device must be intended to benefit patients with a <a href="/facts/Rare_disease/Nu1G7rEw">rare disease</a> or condition (i.e. fewer than 8,000 people in the US annually).<a class="footnote-ref" id="fnref:1" href="#fn:1"><sup>1</sup></a><a class="footnote-ref" id="fnref:2" href="#fn:2"><sup>2</sup></a> The applicant must also show that there is no other way that the device could be brought to market, and that there is no comparable device already available.<a class="footnote-ref" id="fnref:3" href="#fn:3"><sup>3</sup></a> </p> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/Federal_Food%2c_Drug%2c_and_Cosmetic_Act/2WIHtPjC">Federal Food, Drug, and Cosmetic Act</a></li> <li><a href="/facts/Premarket_approval/2WIHtPjC">Premarket approval</a></li></ul> <h2 id="notes">Notes</h2> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>Field, M. Tilson, H. (2006). Safe medical devices for children, National Academies Press <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>Chin, R. Lee B. (2008). Principles and Practice of Clinical Trial Medicine, Elsevier <a href="/wiki/Elsevier" target="_blank">/wiki/Elsevier</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>Health, Center for Devices and Radiological (3 October 2022). "Humanitarian Device Exemption". www.fda.gov. <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm" target="_blank">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> </ol>