Requirements to bring a medical device to market

被引：0

作者：

Buenz, Eric J. ^{[1
,2
,3
]}

Wallace, Victoria M. ^{[4
]}

Friedman, Suzanne Levy ^{[4
]}

机构：

[1] Mayo Clin, Rochester, MN 55905 USA

[2] Device Navigator, Motueka, New Zealand

[3] Nelson Marlborough Inst Technol, Nelson, New Zealand

[4] Hogan Lovells US LLP, Washington, DC USA

来源：

TRENDS IN BIOTECHNOLOGY | 2025年 / 43卷 / 01期

关键词：

PREMARKET APPROVAL; FDA;

D O I：

10.1016/j.tibtech.2024.07.016

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device. © 2024 Elsevier Ltd

引用

页码：4 / 7

页数：4

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