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 submission of premarket notifications for magnetic resonance diagnostic devices. The latest version of the...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published guidance describing the registration process medical devices must go through before placing them on the market in Great Britain...
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 the reporting of computational modeling studies in medical device submissions. The latest version of...
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 balancing premarket and postmarket data collection for medical devices subject to premarket approval....
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a guidance document dedicated to the procedures for handling post-approval studies imposed by premarket approval application orders. The...
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