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Notifiable actions include risk communications, recalls, label changes, reassessments, suspensions or revocations of authorization to prevent serious risk of injury to human health, the agency said. Read More
The FDA issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Read More
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Read More
The FDA has released a new action plan that outlines a potential approach to premarket reviews for artificial intelligence (AI) and machine learning-(ML) software modifications. Read More
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. Read More
The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue and on the use of LPM containment systems. Read More
The European Commission (EC) launched a new registration module in December for Eudamed, the EU database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More
The UK and the European Union wrapped up a landmark trade deal on Dec. 24 — just days before the UK completed its transition out of the EU. Although not specifically targeted at medical devices, the pact acknowledges existing arrangements for devices. Read More
The FDA issued 16 warning letters in 2020 related to COVID-19 diagnostic tests, most of them marketed directly to consumers, and the agency said it will continue targeting those this year. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released guidance that clarifies expectations for notified bodies conducting remote audits during the COVID-19 pandemic. Read More