Beginning Feb. 25, the way that software-based medical devices are regulated in Australia will change, and clinical decision support software (CDSS) that meets the definition of a medical device must…
SGS FIMKO Oy, a Helsinki-based subsidiary of the certification giant SGS, became the 18th notified body to be designated to provide product certifications under the European Medical Device Regulation (MDR).…
The European Commission released new guidance explaining how Legacy Devices will be identified in the Eudamed database and how their unique device identifiers will be generated and assigned. Source: The…
The FDA’s top device officials admit that allowing a flood of COVID-19 diagnostic tests onto the market last year that did not go through the usual clearance or approval steps…
The FDA has named Kevin Fu as acting director of medical device cybersecurity within the Center for Devices and Radiological Health (CDRH) — a newly created position in response to…
Health officials are using new tools to gather postmarket safety data on COVID-19 vaccines, including a new early warning system called V-Safe. Source: The GMP Letter
The European Commission (EC) has agreed on a common framework for the use and validation of rapid antigen tests and COVID-19 test results that EU member states will mutually recognize,…
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct.…
The FDA is introducing a new review program for medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition…
Australia’s Therapeutic Goods Administration is conducting a postmarket review of all COVID-19 point-of-care and laboratory tests listed in the Australian Register of Therapeutic Goods to ensure that they can detect…