Orphan medical devices: addressing the regulatory and access gaps in the EU and US
BackgroundOrphan medical devices remain the blind spot of rare disease policy. While the United States has recognized them since 1990 through the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) framework, the European Union only introduced a non-binding definition in 2024 (MDCG...
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| Principais autores: | , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
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Frontiers Media S.A.
2026-01-01
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| Colecção: | Frontiers in Public Health |
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| Acesso em linha: | https://www.frontiersin.org/articles/10.3389/fpubh.2025.1729821/full |
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