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Validation issues, design control and inadequate corrective and preventive procedures were among the quality system failures cited in a warning letter to Wheat Ridge, Colorado-based DeChoker following a Feb. 17-26 FDA inspection. Read More
The FDA’s Center for Devices and Radiological Health (CDRH) may reject medical devices submitted for premarket approval when the agency is not satisfied that they have adequate cybersecurity, says Kevin Fu, who was appointed to the new position of the agency’s acting director of medical device security earlier this year. Read More
The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities. Read More
The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
Canadian hospitals reported almost 3,500 medical device incidents to Health Canada in 2020, the agency said in a progress report on mandatory reporting requirements introduced as part of the agency’s Medical Device Action Plan. Read More
In the face of increasing cybersecurity threats, the Biden administration is taking several measures to implement stronger cybersecurity standards, including requiring software developers to improve the security of the software supply chain. Read More
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More
International Medical Development did not take adequate corrective and preventive actions for quality deficiencies at its Huntsville, Utah, plant, the FDA found in a Feb. 8-12 inspection. Read More
Eurofins Export Services Oy of Finland has become the 20th notified body designated to certify device products in compliance with the EU Medical Device Regulation (MDR). Read More
The European Commission has launched an online helpdesk for devicemakers who must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26. Read More