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FDA Publishes Order Regarding 510(k) Exemption
The Food and Drug Administration (FDA), the authority responsible for the regulation of medical device circulation in the US, has issued an order excluding certain Class I and Class II medical devices from obligatory...
FDA Guidance on Communication Procedures
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical device circulation, announced proposed changes to communication procedures between medical device manufacturers and other...
FDA Issues Guidance on Testing Information
The Food and Drug Administration (FDA), the US medical device regulating agency, issues detailed guidance on format and content of testing information to be provided in the course of premarket application submission. ...
The FDA’s New Medical Device Regulatory Framework
The Food and Drug Administration (FDA), the US medical device regulating authority, has introduced the new regulatory framework for medical devices. Existing Frameworks: A Short Overview    The Agency published a new...