KUBERAN S and KAMARAJ R 2025. Regulatory Frameworks for Orphan Medical Device: A Comparative Review of USFDA and EU Approaches. The Bioscan. 20, Special Issue-3 (Aug. 2025), 286–293. DOI:https://doi.org/10.63001/tbs.2025.v20.i03.S.I(3).pp286-293.