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Title
FDA Regulation and Approval of Medical Devices: 1976-2020
Authors
Keywords
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Journal
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Volume 326, Issue 5, Pages 420
Publisher
American Medical Association (AMA)
Online
2021-08-03
DOI
10.1001/jama.2021.11171
References
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Related references
Note: Only part of the references are listed.- FDA Approval and Regulation of Pharmaceuticals, 1983-2018
- (2020) Jonathan J. Darrow et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
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- (2019) James W. Salazar et al. JAMA Internal Medicine
- Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
- (2017) Sarah Y. Zheng et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
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- (2017) MILBANK QUARTERLY
- Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI
- (2017) Jonathan J. Darrow et al. NEW ENGLAND JOURNAL OF MEDICINE
- Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014
- (2017) Vinay K. Rathi et al. OTOLARYNGOLOGY-HEAD AND NECK SURGERY
- Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015
- (2017) Comeron W. Ghobadi et al. Journal of the American College of Radiology
- Need for a National Evaluation System for Health Technology
- (2016) Jeffrey Shuren et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015
- (2016) Jessica R. Walter et al. OBSTETRICS AND GYNECOLOGY
- Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
- (2015) Vinay K. Rathi et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Revisiting Essure — Toward Safe and Effective Sterilization
- (2015) Sanket S. Dhruva et al. NEW ENGLAND JOURNAL OF MEDICINE
- Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
- (2015) Jonathan J. Darrow et al. NEW ENGLAND JOURNAL OF MEDICINE
- Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012
- (2015) J. Hwang et al. BMJ Open
- FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012
- (2014) Benjamin N. Rome et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
- (2014) Nicholas S. Downing et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval
- (2014) Ian S. Reynolds et al. JAMA Internal Medicine
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- (2013) Brent M. Ardaugh et al. NEW ENGLAND JOURNAL OF MEDICINE
- Class I recall of defibrillator leads: A comparison of the Sprint Fidelis and Riata families
- (2012) Jeffrey Liu et al. HEART RHYTHM
- Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices
- (2009) Sanket S. Dhruva JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
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