EMV emvision medical devices ltd

NAN has got its De Novo classification by the Trump FDASincethen...

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    NAN has got its De Novo classification by the Trump FDA
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    The FDA has established new regulations for the De Novo classification process. This process provides a pathway for novel medical devices to obtain marketing authorization as Class I or Class II devices when there is no legally marketed predicate device. The final rule outlines criteria for De Novo classification requests, including requirements for format, content, acceptance, granting, declining, and withdrawal. The goal is to ensure appropriate classification while reducing unnecessary regulatory burdens.
 
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