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. 2020 Dec 1;180(12):1701-1703.
doi: 10.1001/jamainternmed.2020.3214.

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

James L Johnston  1 , Sanket S Dhruva  2   3 , Joseph S Ross  4   5   6 , Vinay K Rathi  7   8
Affiliations

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

James L Johnston et al. JAMA Intern Med. .

Abstract

This cross-sectional study characterizes the premarket clinical evidence supporting clearance of moderate-risk novel therapeutic medical devices by the US Food and Drug Administration.

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Conflict of interest statement

Conflicts of Interest Disclosures: Mr Johnston reported grants from the US Food and Drug Administration (FDA) through the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program outside the submitted work. Dr Dhruva reported travel reimbursement from the FDA, the Center for Drug Research and Evaluation/Office of Medical Policy, and the National Evaluation System for Health Technology Coordinating Center, and research grant funding from the Greenwall Foundation and the National Institutes of Health outside the submitted work. Dr Ross reported grants from the FDA, Johnson and Johnson, Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, the National Institutes of Health/National Heart, Lung, and Blood Institute, the Laura and John Arnold Foundation, the Centers for Medicare & Medicaid Services, Medtronic, and the Blue Cross Blue Shield Association outside the submitted work. No other disclosures were reported.

References

    1. US Food and Drug Administration Modernization Act of 1997, Pub L No. 05-115. November 21, 1997. Accessed May 29, 2020. https://www.govinfo.gov/content/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf
    1. Mulero A. FDA’s De Novo program gains momentum. Regulatory Focus. April 4, 2019. Accessed May 29, 2020. https://www.raps.org/news-and-articles/news-articles/2019/4/fdas-de-novo...
    1. Khera R, Girotra S. Cerebral embolic protection devices in transcatheter aortic valve replacement—effective in stroke prevention? JAMA Intern Med. 2020;180(5):785-786. doi:10.1001/jamainternmed.2019.6763 - DOI - PubMed
    1. US Food and Drug Administration . De Novo classification request. November 20, 2019. Accessed May 29, 2020. https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classi...
    1. Rathi VK, Ross JS. Modernizing the FDA’s 510(k) pathway. N Engl J Med. 2019;381(20):1891-1893. doi:10.1056/NEJMp1908654 - DOI - PubMed

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