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,…
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Source: Drug GMP Report
The FDA announced that it is developing guidance on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.”…
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the…