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Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators
Clinical investigators in academic medical centers often perceive federal regulations as a significant obstacle to conducting clinical research. The regulatory authority of the FDA extends to clinical studies of medical devices. Consequently, researchers wishing to conduct device research using FDA-...
שמור ב:
| Main Authors: | , |
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| פורמט: | Artigo |
| שפה: | Inglês |
| יצא לאור: |
2012
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| נושאים: | |
| גישה מקוונת: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3448842/ https://ncbi.nlm.nih.gov/pubmed/22847340 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.231/JIM.0b013e318262df40 |
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