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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
The United Kingdom will launch a new Medical Device Information System (MDIS) in January that aims to improve device monitoring and performance and link them to patient outcomes. 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
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
The FDA cited six devicemakers for problems found during inspections of their facilities, including inadequate validations, medical device reporting and investigations into complaints. Read More
Australia’s Therapeutics Goods Agency (TGA) has issued a new paper on its plan to establish a unique device identification (UDI) system and it wants to hear reactions from device sponsors. Read More
The FDA has updated its electronic medical device reporting (eMDR) system to include new fields for summary reports and combination products to harmonize with international reporting codes. Read More
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body. 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
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More