Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

PubMed

Pathways to first clinical use of a medical device in the United States and European Union - a narrative review.

PMID: 42989485 ·

A, l, i, , M, c, D, o, n, n, e, l, l, ;, , M, a, j, e, l, l, a, , G, e, r, a, g, h, t, y, ;, , E, l, i, s, a, b, e, t, h, , O, l, t, m, a, n, n, s, ;, , O, l, i, v, i, a, , M, c, D, e, r, m, o, t, t, ;, , T, o, m, , M, e, l, v, i, n

JournalExpert review of medical devices
Year
PMID42989485

Abstract

The number of medical devices entering global markets continues to grow, creating challenges for regulators seeking to balance patient access and protection of public health. The United States (US) and the European Union (EU) represent the two predominant regulatory systems for medical devices, yet they differ significantly in pathways to first clinical use and early patient access structure and implementation. This narrative review examines specialised regulatory pathways that enable or acceler

Official Source

View on PubMed →

Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.

↑