Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

Characteristics of pivotal clinical trials of FDA-approved endovascular devices between 2000 and 2018: An interrupted time series analysis

Abstract Background:The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices. Objectives:The purpose of...

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Bibliographic Details
Main Authors: John T. Moon, Menelaos Konstantinidis, Nevon Song, Nariman Nezami, Bill S. Majdalany, Allen Herr, Gary Siskin
Format: Article
Language:English
Published: Cambridge University Press 2023-01-01
Series:Journal of Clinical and Translational Science
Subjects:
Regulatory approval
medical devices
policy
Food and Drug Administration
Online Access:https://www.cambridge.org/core/product/identifier/S2059866123000109/type/journal_article

Internet

https://www.cambridge.org/core/product/identifier/S2059866123000109/type/journal_article

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