A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.

作者信息

Shi Lizheng, Xuan Dennis, Jakovljevic Mihajlo

机构信息

School of Public Health and Tropical Medicine, Health Systems Analytics Research Center, Tulane University, New Orleans, LA, USA.

UNESCO-The World Academy of Sciences TWAS, Trieste, 34100, Italy.

出版信息

Cost Eff Resour Alloc. 2024 Oct 25;22(1):75. doi: 10.1186/s12962-024-00582-9.

DOI:10.1186/s12962-024-00582-9

PMID:39456032

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11515808/

Abstract

摘要

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本文引用的文献

[1]

Development of the China's list of ambulatory care sensitive conditions (ACSCs): a study protocol.

Glob Health Res Policy. 2024-3-19

[2]

Real-world evidence for regulatory decision-making: updated guidance from around the world.

Front Med (Lausanne). 2023-10-30

[3]

Strategic management and organizational culture of medical device companies in relation to corporate performance.

J Med Econ. 2023

[4]

Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies.

Int J Surg. 2023-5-1

[5]

Access and reimbursement pathways for digital health solutions and diagnostic devices: Current scenario and challenges.

Front Med Technol. 2023-2-20

[6]

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

BMJ Surg Interv Health Technol. 2022-11-11

[7]

Real-world data: a brief review of the methods, applications, challenges and opportunities.

BMC Med Res Methodol. 2022-11-5

[8]

HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.

Pharmacoepidemiol Drug Saf. 2023-1

[9]

Health technology assessment of medical devices: current landscape, challenges, and a way forward.

Cost Eff Resour Alloc. 2022-10-5

[10]

Post-market surveillance of medical devices: A review.

Technol Health Care. 2022

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A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.

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