Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017
Published 2021 View Full Article
- Home
- Publications
- Publication Search
- Publication Details
Title
Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017
Authors
Keywords
-
Journal
JAMA Network Open
Volume 4, Issue 5, Pages e217274
Publisher
American Medical Association (AMA)
Online
2021-05-08
DOI
10.1001/jamanetworkopen.2021.7274
References
Ask authors/readers for more resources
Related references
Note: Only part of the references are listed.- Major FDA medical device recalls in ophthalmology from 2003 to 2015
- (2018) Rushi K. Talati et al. CANADIAN JOURNAL OF OPHTHALMOLOGY-JOURNAL CANADIEN D OPHTALMOLOGIE
- Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015
- (2017) Michael J. Connor et al. INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
- 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
- The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices
- (2017) Jordan P. Barker et al. JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME
- US Food and Drug Administration Clearance of Moderate-Risk Otolaryngologic Devices via the 510(k) Process, 1997-2016
- (2017) Vinay K. Rathi et al. OTOLARYNGOLOGY-HEAD AND NECK SURGERY
- Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers
- (2017) Mary E. Lohman et al. JAMA Facial Plastic Surgery
- Analysis of FDA-Approved Orthopaedic Devices and Their Recalls
- (2016) Charles S. Day et al. JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME
- Regulatory approval of new medical devices: cross sectional study
- (2016) Hani J Marcus et al. BMJ-British Medical Journal
- Regulatory approval of new medical devices: cross sectional study
- (2016) Hani J Marcus et al. BMJ-British Medical Journal
- The FDA Process for the Evaluation and Approval of Orthopaedic Devices
- (2016) John S. Kirkpatrick et al. JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS
- How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
- (2015) Andre M. Samuel et al. CLINICAL ORTHOPAEDICS AND RELATED RESEARCH
- Assessment of Cardiovascular and Noncardiovascular Medical Device Recalls
- (2014) John C. Somberg et al. AMERICAN JOURNAL OF CARDIOLOGY
- 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
- The 510(k) Ancestry of a Metal-on-Metal Hip Implant
- (2013) Brent M. Ardaugh et al. NEW ENGLAND JOURNAL OF MEDICINE
- Medical Device Recalls and the FDA Approval Process
- (2011) Diana M. Zuckerman et al. ARCHIVES OF INTERNAL MEDICINE
- Medical Devices — Balancing Regulation and Innovation
- (2011) Gregory D. Curfman et al. NEW ENGLAND JOURNAL OF MEDICINE
- 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
Add your recorded webinar
Do you already have a recorded webinar? Grow your audience and get more views by easily listing your recording on Peeref.
Upload NowBecome a Peeref-certified reviewer
The Peeref Institute provides free reviewer training that teaches the core competencies of the academic peer review process.
Get Started