Transparency and Dermatologic Device Approval by the US Food and Drug Administration | Zendy

Harib Ezaldein | Zendy; Jeffrey F. Scott | Zendy; Emily S. Yin | Zendy; Alessandra Ventura | Zendy; Nicholaas P. DeRuyter | Zendy; David J. Leffell | Zendy

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

Author(s) -

Harib Ezaldein,

Jeffrey F. Scott,

Emily S. Yin,

Alessandra Ventura,

Nicholaas P. DeRuyter,

David J. Leffell

Publication year - 2018

Publication title -

jama dermatology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.128

H-Index - 166

eISSN - 2168-6084

pISSN - 2168-6068

DOI - 10.1001/jamadermatol.2017.5757

Subject(s) - medicine , food and drug administration , vetting , medical emergency , law , political science

The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting measures and can cause understudied changes that lead to drift from a device's original design.

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