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Clinical Evidence Supporting US Food and Drug Administration Clearance of Novel Therapeutic Devices via the De Novo Pathway Between 2011 and 2019
This cross-sectional study characterizes the premarket clinical evidence supporting clearance of moderate-risk novel therapeutic medical devices by the US Food and Drug Administration.
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| Foilsithe in: | JAMA Intern Med |
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| Main Authors: | , , , |
| Formáid: | Artigo |
| Teanga: | Inglês |
| Foilsithe: |
American Medical Association
2020
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| Ábhair: | |
| Rochtain Ar Líne: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7551221/ https://ncbi.nlm.nih.gov/pubmed/33044513 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2020.3214 |
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