Postmarket Modifications of High-risk Plastic Surgery Devices

BACKGROUND: In the United States, high-risk medical devices must be cleared through the premarket approval (PMA) pathway, which requires clinical evidence ensuring safety and efficacy. Approved devices can be modified and reintroduced to market without additional study through the PMA supplemental r...

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Detalles Bibliográficos
Autores principales: Olaiya, Oluwatobi R., Oyesile, Doyinsola, Stone, Nicholas, Mbuagbaw, Lawrence, McRae, Mark H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2020
Materias:
Special Topic
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7159931/
https://www.ncbi.nlm.nih.gov/pubmed/32309074
http://dx.doi.org/10.1097/GOX.0000000000002621

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7159931/
https://www.ncbi.nlm.nih.gov/pubmed/32309074
http://dx.doi.org/10.1097/GOX.0000000000002621

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