Literature DB >> 24664113

Premarket approval supplement pathway: do we know what we are getting?

Sarah Y Zheng, Rita F Redberg.   

Abstract

Mesh：

Year:  2014        PMID： 24664113     DOI： 10.7326/M13-2931

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN： 0003-4819            Impact factor:   25.391


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  6 in total

1.  How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Authors:  Andre M Samuel; Vinay K Rathi; Jonathan N Grauer; Joseph S Ross
Journal:  Clin Orthop Relat Res       Date:  2015-11-19       Impact factor: 4.176

2.  CORR Insights®: How Do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?

Authors:  Carlos J Lavernia; Jesus M Villa
Journal:  Clin Orthop Relat Res       Date:  2016-01-14       Impact factor: 4.176

3.  Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

Authors:  Harib H Ezaldein; Jeffrey F Scott; Emily S Yin; Alessandra Ventura; Nicholaas P DeRuyter; David J Leffell
Journal:  JAMA Dermatol       Date:  2018-03-01       Impact factor: 10.282

Review 4.  FDA Policy and Cardiovascular Medicine.

Authors:  Joseph S Ross; Aaron S Kesselheim
Journal:  Circulation       Date:  2015-09-22       Impact factor: 29.690

5.  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

6.  Postmarket Modifications of High-risk Plastic Surgery Devices.

Authors:  Oluwatobi R Olaiya; Doyinsola Oyesile; Nicholas Stone; Lawrence Mbuagbaw; Mark H McRae
Journal:  Plast Reconstr Surg Glob Open       Date:  2020-02-19
  6 in total

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