The FDA and the Vaginal Mesh Controversy—Further Impetus to Change the 510(k) Pathway for Medical Device Approval-Reference-Cited by-同舟云学术

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The FDA and the Vaginal Mesh Controversy—Further Impetus to Change the 510(k) Pathway for Medical Device Approval

Published:2016-02-01 Issue:2 Volume:176 Page:277
ISSN:2168-6106
Container-title:JAMA Internal Medicine
language:en
Short-container-title:JAMA Intern Med

Author:

Jacoby Vanessa L.¹,Subak Leslee²,Waetjen L. Elaine³

Affiliation:

1. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco

2. Departments of Obstetrics, Gynecology, and Reproductive Sciences; Urology; and Epidemiology & Biostatistics, University of California, San Francisco

3. Department of Obstetrics and Gynecology, University of California, Davis

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Is the 510(k) Pathway Robust Enough for the Era of AI?;Applied Radiology;2023-03-01

2. Recalls of Moderate‐ and High‐Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003‐2019;Otolaryngology–Head and Neck Surgery;2022-03-15

3. Minimal Access Urogynaecology;Gynaecological Endoscopic Surgery;2022

4. Device Safety;Otolaryngologic Clinics of North America;2019-02

5. Pelvic Organ Prolapse and Perineal Hernias;Fundamentals of Anorectal Surgery;2018-12-25

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