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The FDA cited many reportable events that could be linked to the decontamination system and said the company should have reported them to the agency. 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
In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those for home use by lay-users. Read More
FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA. Read More
Australia’s Therapeutics Goods Agency (TGA) has issued a new consultation paper on its plan to establish a unique device identification (UDI) system and it wants to hear from device sponsors. Read More