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Mytrex, a manufacturer of personal emergency response systems, received a Form 483 from the FDA for lack of equipment testing and inadequate recordkeeping, among other lapses observed during an inspection of the company’s South Jordan, Utah, facility. Read More
The EU’s Medical Device Coordination Group (MDCG) has released new guidance on requirements created by the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) for devicemakers’ “authorized representatives,” including who, when and how to register. Read More
Ionocare has received 510(k) marketing clearance from the FDA to remanufacture and market a used DaVinci robotic surgical system attachment — 8 mm monopolar curved scissors for the EndoWrist Si system. Read More
The Medical Device Innovation Consortium (MDIC) has published a new step-by-step framework approach to integrating patient preferences into medical device clinical trials. Read More
The FDA has granted Grifols marketing clearance for its AlphaID At Home direct-to-consumer screening test for alpha-1 antitrypsin deficiency, which can cause a hereditary form of emphysyma as well as cirrhosis of the liver. Read More
Wintech Medipro, a manufacturer of surgical and medical face masks in Katy, Texas, has drawn a Form 483 for a host of observations, including inadequate complaint handling, medical device reporting and employee training. Read More
Nuheara has gained FDA clearance for its HP Hearing Pro, meeting both FDA Class II and OTC requirements for hearing aids in a wireless ear bud design. Read More
Rockwell Medical received a Form 483 after the FDA observed inadequate corrective and preventive actions (CAPA) and equipment maintenance problems in a July inspection of the company’s Grapevine, Texas, facility. Read More
Changes in definitions and more specific requirements are the hallmarks of the FDA’s proposal to bring its Quality System Regulation (QSR) more in line with the international standard ISO 13485, but the overall principles of the QSR remain, says one regulatory expert. Read More