Aug 3, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to implanted brain-computer interface (BCI) devices for patients with paralysis or amputation. Table of...
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Apr 13, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
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Apr 9, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD). The document is intended to...
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Apr 7, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the types of communication during the review of medical device submissions. The document is intended to...
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Apr 7, 2021
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the eCopy Program for medical device submission. The present document constitutes an updated version of...
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