Literature DB >> 32704171

Early experience with the FDA's Breakthrough Devices program.

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

Abstract

Mesh：

Year:  2020        PMID： 32704171     DOI： 10.1038/s41587-020-0636-7

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  2 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

Review 2.  Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.

Authors:  Aaron E Lottes; Kenneth J Cavanaugh; Yvonne Yu-Feng Chan; Vincent J Devlin; Craig J Goergen; Ronald Jean; Jacqueline C Linnes; Misti Malone; Raquel Peat; David G Reuter; Kay Taylor; George R Wodicka
Journal:  J Cardiovasc Transl Res       Date:  2022-03-14       Impact factor: 3.216
  2 in total

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