FDA
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
The Health Canada, the Canadian authority responsible for medical devices regulation, issued guidance dedicated to the application for a new license of making amendments to existing one for private label medical device. The document is intended to assist all parties...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued guidance documents dedicated to certain medical devices becoming significantly important in the current environment: first guidance covers the...
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...
