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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 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 EU Medical Device Regulation (MDR), which went into effect on May 26, has caused some countries, including Switzerland, to lose direct access to the EU single market as they must update their mutual equivalency agreements in order to trade with the bloc. 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
Australia’s Therapeutic Goods Administration is proposing to ease certain requirements in its regulatory framework for custom-made and 3D-printed devices that became effective in February. Read More
Although many diagnostics firms were hoping that the effective date of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) would be further delayed, the EU Medical Device Coordination Group (MDCG) unveiled a joint implementation and preparedness plan for the IVDR indicating that the new requirements will go into effect as planned. Read More
Groups that will be impacted by the EU’s In Vitro Diagnostic Regulation (IVDR) are calling for urgent action to further delay its May 26, 2022 effective date and for a phased implementation. Read More
The FDA’s Breakthrough Device designation is intended to give patients more timely access to new devices by expediting their development and review. Read More