Jan 15 - 4:01
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...
Jan 3 - 5:36
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...
Dec 30 - 3:03
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...
Dec 27 - 6:47
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. ...
Dec 17 - 6:47
The US Food and Drug Administration (FDA), the authority responsible for premarket approval of medical devices, issued updated rules replacing paper submission form with the electronic form. The Scope Of New Changes ...
Dec 12 - 7:30
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...
