The GMP Letter
TGA Issues Guidance on Clinical Decision Support Software
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 be included in the Australian Register of Therapeutic Goods. Source: The GMP Letter
Read MoreNew MDR Notified Body Designated in Finland
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). Source: The GMP Letter
Read MoreEC Details How Legacy Devices Will Be Managed in Eudamed
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 GMP Letter
Read MoreFDA’s Device Center Has COVID Test Regrets
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 was a “flawed” approach. Source: The GMP Letter
Read MoreFDA Appoints Kevin Fu As First Medical Device Cybersecurity Chief
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 the agency’s growing concerns about cybersecurity threats. Source: The GMP Letter
Read MoreNew Postmarket Surveillance Tool for COVID-19 Vaccines
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
Read MoreEC Agrees on Common List of COVID-19 Rapid Antigen Tests
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 well as a standardized dataset to be included in test result certificates. Source: The GMP Letter
Read MoreNew York Contract Manufacturer Hit for Repeat Observations
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. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Source: The GMP Letter
Read MoreFDA Issues Final Guidance on New Review Path for Safer Technologies
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 deemed less serious than those eligible for the breakthrough devices program. Source: The GMP Letter
Read MoreTGA Investigates COVID-19 Tests and Emerging Variants
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 emerging SARS-CoV-2 genetic variants. Source: The GMP Letter
Read More