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Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

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Year: 2022
Type: review
Source: Journal of Cardiovascular Translational Research
DOI: 10.1007/s12265-022-10232-1
Authors: Aaron E. Lottes, Kenneth J. Cavanaugh, Yvonne Yu-Feng Chan, Vincent J. Devlin, Craig J. Goergen, Ronald Jean, Jacqueline C. Linnes, Misti Malone, Raquel Peat, David G. Reuter, Kay Taylor, George R. Wodicka
Institutions: Purdue University West Lafayette, United States Food and Drug Administration, Center for Devices and Radiological Health, Seattle Children's Hospital, Becton Dickinson (United States)
Language: English

Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
SDG: Good health and well-being

Open Access status: bronze

Funders: Purdue University, Indiana Clinical and Translational Sciences Institute, National Institutes of Health, National Center for Advancing Translational Sciences
Awards: G3754633476, Indiana Clinical and Translational Sciences Institute
OpenAlex ID: W4220914533
FWCI: 1.88
Cites: 12
Cited by: 71
Related to: 10
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