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. 2022 May;99(6):1784-1788.
doi: 10.1002/ccd.30151. Epub 2022 Apr 29.

Regulatory strategies for early device development and approval

David R Holmes  1 , Rick Geoffrion  2 , Jon Hunt  3 , Robert Chip Hance  4 , Martin B Leon  5 , Michael J Mack  6 , Aaron V Kaplan  7
Affiliations

Regulatory strategies for early device development and approval

David R Holmes et al. Catheter Cardiovasc Interv. 2022 May.

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.

Keywords: interventional devices/innovation; new devices (in general); structural heart disease intervention.

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References

REFERENCES

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    1. 21st Century Cures Act Pub.L. 114-255. 2016. https://www.congress.gov/bill/114th-congress/house-bill/34
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