Literature DB >> 33044513

Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019.

James L Johnston1, Sanket S Dhruva2,3, Joseph S Ross4,5,6, Vinay K Rathi7,8.   

Abstract

Mesh:

Year:  2020        PMID: 33044513      PMCID: PMC7551221          DOI: 10.1001/jamainternmed.2020.3214

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


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  3 in total

1.  Modernizing the FDA's 510(k) Pathway.

Authors:  Vinay K Rathi; Joseph S Ross
Journal:  N Engl J Med       Date:  2019-10-23       Impact factor: 91.245

2.  Cerebral Embolic Protection Devices in Transcatheter Aortic Valve Replacement-Effective in Stroke Prevention?

Authors:  Rohan Khera; Saket Girotra
Journal:  JAMA Intern Med       Date:  2020-05-01       Impact factor: 21.873

3.  Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

Authors:  Vinay K Rathi; Harlan M Krumholz; Frederick A Masoudi; Joseph S Ross
Journal:  JAMA       Date:  2015-08-11       Impact factor: 56.272

  3 in total
  3 in total

Review 1.  [The problem of medical overuse : Finding a definition and solutions].

Authors:  T Gamstätter
Journal:  Internist (Berl)       Date:  2021-02-13       Impact factor: 0.743

2.  Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Authors:  Sanket S Dhruva; Jonathan J Darrow; Aaron S Kesselheim; Rita F Redberg
Journal:  J Gen Intern Med       Date:  2022-02-09       Impact factor: 5.128

3.  Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice.

Authors:  Sanket S Dhruva; Shumin Zhang; Jiajing Chen; Peter A Noseworthy; Amit A Doshi; Kolade M Agboola; Jeph Herrin; Guoqian Jiang; Yue Yu; Guy Cafri; Kimberly Collison Farr; Keondae R Ervin; Joseph S Ross; Paul M Coplan; Joseph P Drozda
Journal:  JAMA Netw Open       Date:  2022-08-01
  3 in total

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