Mar 21, 2022
FDA
The new article provides additional details regarding the regulatory framework for early feasibility studies and covers the associated aspects, including, inter alia, targeting approval. Table of Contents The Food and Drug Administration (FDA or...
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Mar 12, 2022
FDA
The present article provides a brief overview of the existing regulatory framework in the sphere of investigational device exemptions and describes special pathways to be applied to ensure the availability of novel medical devices. Table of...
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Jul 12, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the early collaboration meetings in the context of the FDA Modernization Act (FDAMA). The latest version...
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May 24, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the non-clinical testing and clinical considerations of implanted brain-computer interface devices. The present...
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