Food and Drug Administration's Humanitarian Device Exemption Marketing Approval Pathway: Insights for Developing Devices for Rare Diseases
Author:
Affiliation:
1. Office of Orphan Products Development, Office of Special Medical Programs, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 e-mail:
Abstract
Publisher
ASME International
Subject
Biomedical Engineering,Medicine (miscellaneous)
Link
http://asmedigitalcollection.asme.org/medicaldevices/article-pdf/doi/10.1115/1.4036333/6402147/med_011_03_034701.pdf
Reference9 articles.
1. Clinical Research for Rare Disease: Opportunities, Challenges, and Solutions;Mol. Genet. Metab.,2009
2. Humanitarian Device Exemption (HDE): Questions and Answers—Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff;The U.S. Food and Drug Administration,2014
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