FDA
The Food and Drug Administration (FDA), the US medical device regulating authority, has published a notice dedicated to the pilot program for a request for designation (RFD) and pre-request for designation (Pre-RFD) electronic submissions. The document was published...
FDA
The Food and Drug Administration (FDA) has published an updated fee schedule for medical device users – the companies applying for FDA approval for their medical devices. According to the Medical Device User Fee Amendments (MDUFA), most of the entities...
FDA
The Food and Drug Administration (FDA) announced an exemption from premarket notification for certain Class II medical devices. FDA Exemption in Brief The FDA has published an order indicating class II medical devices to be exempt from 510(k) premarket notification...
COVID-19
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has issued a final version of the guidance dedicated to the multiple function device products. Regulatory Background The regulatory framework to be applied for a...
COVID-19
The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools. FDA: Regulatory Background In order to...
COVID-19
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medicinal products and medical devices, has published an enforcement policy dedicated to viral transport media in the context of the outbreak of the Coronavirus Disease 2019...
