Deadly Legacy—The 510(k) Path to Medical Device Clearance-Reference-Cited by-同舟云学术

Deadly Legacy—The 510(k) Path to Medical Device Clearance

Published:2021-12-15 Issue: Volume: Page:
ISSN:2168-6254
Container-title:JAMA Surgery
language:en
Short-container-title:JAMA Surg

Author:

Adashi Eli Y.¹,Robison Katina M.²,Cohen I. Glenn³

Affiliation:

1. Brown University, Providence, Rhode Island

2. Program in Women’s Oncology, Brown University, Providence, Rhode Island

3. Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, Massachusetts

Publisher

American Medical Association (AMA)

Subject

Surgery

Link

https://jamanetwork.com/journals/jamasurgery/articlepdf/2787211/jamasurgery_adashi_2021_vp_210017_1639419806.96363.pdf

Reference9 articles.

1. Left to their own devices: breakdowns in United States medical device premarket review.;Hines;PLoS Med,2010

2. Medical device recalls and the FDA approval process.;Zuckerman;Arch Intern Med,2011

3. US Food and Drug Administration. UPDATE: perform only contained morcellation when laparoscopic power morcellation is appropriate: FDA Safety Communication. December 29, 2020. Accessed August 15, 2021. https://www.fda.gov/medical-devices/safety-communications/update-perform-only-contained-morcellation-when-laparoscopic-power-morcellation-appropriate-fda.

4. US Government Accountability Office. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling. February 2017. Accessed August 15, 2021. https://www.gao.gov/assets/gao-17-231.pdf.

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