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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-...

Täydet tiedot

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Bibliografiset tiedot
Päätekijät: Blair Holbein, M. E., Berglund, Jelena Petrovic
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: 2012
Aiheet:
Linkit: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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