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A study assessing the FDA’s De Novo premarket review pathway found that some devices received clearance without supporting data from pivotal clinical trials. Read More
The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic. Read More
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. Read More
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Read More
Becton Dickinson is suing clinical diagnostics company BioMedomics for refusing to refund $6.1 million in payments it made for a COVID-19 serology test kit that it planned to distribute, but that the FDA later refused to approve. Read More
The FDA found orthopedic devicemaker BioSculptor’s production processes were “not developed, controlled and monitored to ensure that a device conforms to its specifications,” according to a 483 the firm received following an FDA inspection at its Hialeah, Florida facility. Read More
Inadequate design validation procedures and a lack of environmental controls were among the quality system lapses observed during an FDA inspection of Pegasus Research’s Santa Ana, California facility. Read More
Inadequate corrective and preventive action procedures and failure to implement written medical device reporting (MDR) procedures landed Pan Medical a 483 following an inspection at the firm’s Largo, Florida facility. Read More
Effective Oct. 1, Australia’s Therapeutic Goods Administration is requiring devicemakers of Class I non-measuring, non-sterile devices to provide a declaration of conformity with their applications to list on the Australian Register of Therapeutic Goods (ARTG). Read More