PubMed

医療機器製造業者が新型FDA製品コードを取得する競争優位性：独自の調査研究。

PMID: 42527474 · 2025-09-16

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学術誌npj health systems

年2025-09-16

PMID42527474

抄録

The FDA classifies medical devices by risk, assigning each a product code (PC) that determines its regulatory pathway for clearance. Novel PCs are created when new technologies raise safety or efficacy questions not addressed by existing codes. This analysis examines whether novel PCs provide strategic or regulatory advantages to first-mover manufacturers and how PC use evolves. Using FDA clearance data from 2000-2024, we analyzed the origin, usage patterns, and review timelines of novel PCs acr

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