Jennifer L. Brown’s Post

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Neuroscience Ph.D. & J.D. passionate about formulating strategies to meet client goals at the intersection of science, law and policy.

Is your in vitro diagnostic product labeled for Research Use Only (RUO) or for Investigational Use Only? Make sure the labeling matches such a use, or the FDA could find that the device is intended for clinical diagnostic use instead. 📧 FDA's newly issued warning letter contains some factors to consider when determining whether associated materials and practices might be contrary to a product's ROU categorization. https://lnkd.in/ghSvDMrm #IVD #RUO #meddevice #compliance #FDA #regulatory 

Agena Bioscience, Inc. - 665159 - 03/21/2024

Agena Bioscience, Inc. - 665159 - 03/21/2024

fda.gov

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