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A 510(k) ancestry of robotic surgical systems.
Int J Surg
February 2022
Department of Health Policy and Research, Weill Cornell Medical College, 570 Lexington Avenue, New York, NY, 10022, United States Department of Health Policy and Research, Weill Cornell Medical College, United States University of California, San Francisco School of Medicine, San Francisco, USA Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco School of Medicine, San Francisco, USA.
Mapping the genealogy of medical device predicates in the United States.
PLoS One
November 2021
Science, Mathematics and Computer Science Program, Montgomery Blair High School, Silver Spring, MD, United States of America.
Background: In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway.
View Article and Find Full Text PDFThe 510(k) Ancestry of Transvaginal Mesh: When the Subject Is Not a Predicate.
JAMA Surg
August 2021
Women's College Hospital Institute for Health System Solutions and Virtual Care, Women's College Research Institute, Department of Surgery, Women's College Hospital, Toronto, Ontario, Canada.
The regulatory ancestral network of surgical meshes.
PLoS One
December 2018
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Headington, Oxford, United Kingdom.
Background: All surgical meshes entering the U.S. market have been cleared for clinical use by the 510(k) process of the Food and Drug Administration (FDA), in which devices simply require proof of "substantial equivalence" to predicate devices, without the need for clinical trials.
View Article and Find Full Text PDFThe 510(k) ancestry of a metal-on-metal hip implant.
N Engl J Med
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Framingham Heart Study, Boston University School of Medicine, Boston, USA.
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