COVID-19
The Food and Drug Administration (FDA) has issued a special warning describing the risk for patients associated with the protective barrier enclosures without negative pressure used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the cutaneous electrodes for recording purposes. In particular, the document constitutes a final version of the guidance, while the initial draft was published by the FDA in...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the safety and performance pathway as it applies to medical devices. Due to its legal nature, the document does not establish mandatory rules the industry representatives shall follow. It only...
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...
