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<p>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 across filing types and specialties. We find that initial filers of novel PCs often experience a delay before reuse, suggesting a period of de facto exclusivity. This exclusivity varies by pathway: traditional 510(k), PMA, and Post-NSE De Novo filings are associated with longer exclusivity periods, while Direct De Novo filings offer shorter windows and longer review times despite producing most novel PCs. These trends indicate acquiring novel PCs may benefit manufacturers across risk classes and specialties.</p>

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Competitive value of acquiring novel FDA product codes for medical device manufacturers: an original investigation

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月16日

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  • Karl L. Schumacher,
  • Paul-Elie Nauleau,
  • Prashanth Asuri

摘要

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 across filing types and specialties. We find that initial filers of novel PCs often experience a delay before reuse, suggesting a period of de facto exclusivity. This exclusivity varies by pathway: traditional 510(k), PMA, and Post-NSE De Novo filings are associated with longer exclusivity periods, while Direct De Novo filings offer shorter windows and longer review times despite producing most novel PCs. These trends indicate acquiring novel PCs may benefit manufacturers across risk classes and specialties.