August 7, 2025The Bioscan.Open Access

Regulatory Frameworks for Orphan Medical Device: A Comparative Review of USFDA and EU Approaches

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Discussion

This review highlights differences in orphan device regulations between USFDA and EU, suggesting mutual learning may enhance innovation and safety.

The USFDA accelerates orphan device approval through relaxed standards under programs like Humanitarian Use Device.
In contrast, the EU's Medical Device Regulation enforces stricter conformity assessments and clinical evidence requirements.
This comparative analysis addresses the definitions, approval methods, and challenges of orphan devices in both regions.
Highlighting the potential for harmonization can improve patient safety and foster innovation for rare medical conditions.

KUBERAN et al. (2025) studied this question.

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This review highlights differences in orphan device regulations between USFDA and EU, suggesting mutual learning may enhance innovation and safety.