Literature DB >> 31644865

Modernizing the FDA's 510(k) Pathway.

Vinay K Rathi1, Joseph S Ross1.   

Abstract

Mesh:

Year:  2019        PMID: 31644865     DOI: 10.1056/NEJMp1908654

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


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  3 in total

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

Authors:  James L Johnston; Sanket S Dhruva; Joseph S Ross; Vinay K Rathi
Journal:  JAMA Intern Med       Date:  2020-12-01       Impact factor: 21.873

Review 2.  Evaluating the efficacy of bronchoscopy for the diagnosis of early stage lung cancer.

Authors:  David M DiBardino; Anil Vachani; Lonny Yarmus
Journal:  J Thorac Dis       Date:  2020-06       Impact factor: 2.895

Review 3.  The case for an academic discipline of medical device science.

Authors:  Anne Lübbeke; James A Smith; Daniel Prieto-Alhambra; Andrew J Carr
Journal:  EFORT Open Rev       Date:  2021-03-01
  3 in total

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