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…
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,…
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…
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…
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. Source: The GMP Letter
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…
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…
FDA investigators observed problems with equipment calibration, validation studies and design verifications among other failings during inspections of five device manufacturing facilities. Source: The GMP Letter
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…
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…