Literature DB >> 31355877

Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices.

Rita F Redberg1,2,3, Sanket S Dhruva1,4.   

Abstract

Year:  2019        PMID： 31355877     DOI： 10.1001/jama.2019.10191

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  4 in total

1.  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

2.  The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.

Authors:  Andrew Zhu; Xiaohan Ying; Christian A Pean; Neil P Sheth; Michael B Cross; Alejandro Gonzalez Della Valle; Ajay Premkumar
Journal:  HSS J       Date:  2022-06-20

3.  Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis.

Authors:  Lucas Lauder; Bruno R da Costa; Sebastian Ewen; Sean S Scholz; William Wijns; Thomas F Lüscher; Patrick W Serruys; Elazer R Edelman; Davide Capodanno; Michael Böhm; Peter Jüni; Felix Mahfoud
Journal:  Eur Heart J       Date:  2020-07-14       Impact factor: 35.855

4.  Pathways to breast cancer screening artificial intelligence algorithm validation.

Authors:  Christoph I Lee; Nehmat Houssami; Joann G Elmore; Diana S M Buist
Journal:  Breast       Date:  2019-09-09       Impact factor: 4.380
  4 in total

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