Cargando…
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...
| Autores principales: | , , , , |
|---|---|
| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Wolters Kluwer Health
2020
|
| Materias: | |
| 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 |