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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
The FDA found Anodyne Therapy’s validation and risk analyses were inadequate, and reports of radiation were not sent to the FDA, according to a 483 the firm received follow an agency inspection of its Oldsmar, Florida facility. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s medical device, drug evaluation, and biologics evaluation centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
Devicemaker Genicon failed to provide adequate resources for quality control operations to ensure that devices were designed and produced according to FDA regulations, according to a 15-item Form 483 the firm received following an inspection of its Winter Park, Florida facility. Read More
Failure to validate the design of its Specboard, which is used to localize suspect breast lesions during surgery, was among the quality system lapses the FDA observed during an inspection of Macbrud’s Miami, Florida facility. Read More
Australia plans to make more in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza beginning Oct. 1, although self-tests for cancer and genetic testing will not be allowed to be sold to consumers, the Therapeutic Goods Administration (TGA) said. Read More
The FDA clarified in new proposed rule how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More