Regulatory strategies for early device development and approval

David R. Holmes; Rick Geoffrion; Jon Hunt; Robert ”Chip” Hance; Martin B. Leon; Michael J. Mack; Aaron V. Kaplan

doi:10.1002/ccd.30151

Regulatory strategies for early device development and approval

David R. Holmes, Rick Geoffrion, Jon Hunt, Robert ”Chip” Hance, Martin B. Leon, Michael J. Mack, Aaron V. Kaplan

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease.

Original language	English (US)
Pages (from-to)	1784-1788
Number of pages	5
Journal	Catheterization and Cardiovascular Interventions
Volume	99
Issue number	6
DOIs	https://doi.org/10.1002/ccd.30151
State	Published - May 1 2022

Keywords

interventional devices/innovation
new devices (in general)
structural heart disease intervention

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1002/ccd.30151

Cite this

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abstract = "The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease.",

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AU - Hance, Robert ”Chip”

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AU - Mack, Michael J.

AU - Kaplan, Aaron V.

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Regulatory strategies for early device development and approval

Abstract

Keywords

ASJC Scopus subject areas

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