FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, issued guidance describing an enforcement policy for ventilators, accessories and other respiratory devices in the context of the novel coronavirus...
FDA
The Food and Drug Administration (FDA) issued a policy on the Remote Auditing Pilot Program which would be implemented in the course of the Medical Device Single Audit Program (MDSAP). At the moment the new program, which is part of the Device Marketing Authorization...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance dedicated to enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance highlighting the way the clinical trials of medical products should be conducted during the COVID-19 pandemic. The scope of the document covers all...
