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...
Australia and Oceania
The Australian Therapeutic Goods Administration (ARTG) and the TGA, an authority responsible for medical device regulations, has updated its guidance on thermometers and other temperature measuring medical devices and products used in the context of Coronavirus...
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...
COVID-19
The LÆGEMIDDELSTYRELSEN, the Danish Medicines Agency, published guidance describing the extraordinary measures for clinical trials in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). COVID-related Regulatory Background The Danish Medicines...
COVID-19
The European Commission (EC), the European body responsible for medical device regulation, published a summary dedicated to the availability and capacity of notified bodies to perform the conformity assessment of medical devices and in vitro diagnostic medical devices...
