FDA
The article highlights the aspects related to physical laboratory testing to be conducted by the parties responsible for magnetic resonance products to ensure they are safe and efficient when used for the initial intended purpose.
HPRA
The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
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...
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