Our Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

Slider
FDA Guidance on Computer-Assisted Detection Devices
The US Food and Drug Administration (FDA) published guidance dedicated to 510(k) premarket notification submissions related to computer-assisted detection devices applied to radiology images and radiology medical...
FDA Guidance on Application Requirements for Devices
The Food and Drug Administration (FDA), the US agency responsible for medical device regulation, issues guidance dedicated to requirements for certain Class II applications. Medical Devices for Percutaneous Coronary...
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...