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Literature DB >> 25265502

The Food and Drug Administration's unique device identification system: better postmarket data on the safety and effectiveness of medical devices.

Josh Rising¹, Ben Moscovitch¹.

Abstract

Mesh：

Year: 2014 PMID： 25265502 DOI： 10.1001/jamainternmed.2014.4195

Source DB: PubMed Journal: JAMA Intern Med ISSN： 2168-6106 Impact factor: 21.873

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7 in total

1. Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

Authors: Joseph S Ross; Jonathan Bates; Craig S Parzynski; Joseph G Akar; Jeptha P Curtis; Nihar R Desai; James V Freeman; Ginger M Gamble; Richard Kuntz; Shu-Xia Li; Danica Marinac-Dabic; Frederick A Masoudi; Sharon-Lise T Normand; Isuru Ranasinghe; Richard E Shaw; Harlan M Krumholz
Journal: Med Devices (Auckl) Date: 2017-08-16

2. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

Authors: Jonathan Bates; Craig S Parzynski; Sanket S Dhruva; Andreas Coppi; Richard Kuntz; Shu-Xia Li; Danica Marinac-Dabic; Frederick A Masoudi; Richard E Shaw; Frederick Warner; Harlan M Krumholz; Joseph S Ross
Journal: Pharmacoepidemiol Drug Saf Date: 2018-06-12 Impact factor: 2.890

3. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

Authors: Sarah Y Zheng; Sanket S Dhruva; Rita F Redberg
Journal: JAMA Date: 2017-08-15 Impact factor: 56.272

The Food and Drug Administration's unique device identification system: better postmarket data on the safety and effectiveness of medical devices.

1. Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

2. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

3. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

4. Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance.

5. Landscape of Cardiovascular Device Registries in the United States.

6. Medical device surveillance with electronic health records.

7. Safety of Medical Devices in Poland - Analysis of Withdrawn and Suspended Certificates of Compliance.