KUBERAN S, and KAMARAJ R. “Regulatory Frameworks for Orphan Medical Device: A Comparative Review of USFDA and EU Approaches”. The Bioscan 20, no. Special Issue-3 (August 7, 2025): 286–293. Accessed December 29, 2025. https://thebioscan.com/index.php/pub/article/view/3882.