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Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
IMPORTANCE: High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. OBJECTIVE: To charac...
Wedi'i Gadw mewn:
| Cyhoeddwyd yn: | JAMA |
|---|---|
| Prif Awduron: | , , |
| Fformat: | Artigo |
| Iaith: | Inglês |
| Cyhoeddwyd: |
American Medical Association
2017
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| Pynciau: | |
| Mynediad Ar-lein: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5817595/ https://ncbi.nlm.nih.gov/pubmed/28810022 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2017.9414 |
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