Clinical Perspective—Early Feasibility Device Medical Studies in the United States

Author:

Holmes David R.,Shuren Jeff,Califf Robert,Zuckerman Bram,Abel Dorothy,Farb Andrew,Leon Martin,Mack Michael

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference5 articles.

1. Shuren J. Statement of Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services Before the Committee on Health, Education, Labor and Pensions, United States Senate. April 28, 2015. Available at: http://www.help.senate.gov/imo/media/doc/Shuren3.pdf. Accessed November 16, 2015.

2. Cadet JV. Future of CV innovation: The world is flattening. Cardiovascular Business. September 19, 2012. Available at: http://www.cardiovascularbusiness.com/topics/healthcare-economics/future-cvinnovation-world-flattening. Accessed January 5, 2016.

3. U.S. FDA. Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff, 2013. Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf. Accessed November 15, 2015.

4. Centers for Medicare and Medicaid Services. Medicare Coverage Related to Investigational Device Exemption (IDE) Studies. August 28, 2015. (Available at: https://www.cms.gov/Medicare/Coverage/IDE. Accessed November 15, 2015.

5. Centers for Medicare and Medicaid Services. Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies. January 1, 2015. Available at: https://www.cms.gov/Medicare/Coverage/IDE/Downloads/MM8921.pdf. Accessed November 15, 2015.

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2. Regulatory strategies for early device development and approval;Catheterization and Cardiovascular Interventions;2022-04-29

3. Early Feasibility Studies in Evolution;Journal of the American College of Cardiology;2021-07

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