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Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story
Circulation: Cardiovascular Quality and OutcomesBackground: Following regulatory approval, medical devices may be used off-label. Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and
Andrew M Goldsweig +2 more
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Performance Standards for Medical Device Approvals
Archives of Otolaryngology - Head and Neck Surgery, 1995As a result of the controversy concerning the safety of silicone and other permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small sample of applications by manufacturers. The Food and Drug Administration's "Final Report of the Committee for Clinical Review" found that clinical ...
F H, Silver, A I, Glasgold
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Regulatory strategies for early device development and approval
Catheterization and Cardiovascular Interventions, 2022AbstractThe 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.
David R. Holmes +6 more
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The FDA Process for the Evaluation and Approval of Orthopaedic Devices
Journal of the American Academy of Orthopaedic Surgeons, 2008The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety.
John S, Kirkpatrick, Theodore, Stevens
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Analysis of FDA-Approved Orthopaedic Devices and Their Recalls
Journal of Bone and Joint Surgery, 2016Background: The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to ...
Charles S, Day +4 more
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Drug and Device Approval Highlights from 2001
The Nurse Practitioner, 2002The U.S. Food and Drug Administration approved more than 100 drugs and devices in 2001. This article discusses several of the new approvals, including ophthalmic drugs, contraceptive therapies, mental health medications, and medical devices.
Deborah, Kupecz, Candace, Berardinelli
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Orthopaedic Device Approval Through the Premarket Approval Process
Journal of Bone and Joint Surgery, 2017Abstract: The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device.
Brian W, Yang +2 more
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FDA-Approved Densitometry Devices
2003The devices discussed in this chapter are available in the United States for clinical use. The specifications were provided by the manufacturers and are subject to change without notice as devices are continually upgraded to reflect advances in the technology. The categories of information provided by each manufacturer may vary slightly. All categories
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