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Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix, Arizona facility. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance that clarifies the deadlines for stand-alone software that must carry the UK conformity assessment mark (UKCA) for applications regulated as medical devices. Read More
Health Canada has issued new guidance for devicemakers on submitting “summary reports” and conducting issue-related analyses of safety and effectiveness for devices approved for marketing in Canada — two requirements recently added to Canadian regulations. 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’s Center for Devices and Radiological Health (CDRH) is getting ready to launch its Accreditation Scheme for Conformity Assessment (ASCA) pilot program allowing accredited testing laboratories to assess the conformance of a device with FDA-recognized standards. 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
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. 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