The U.S. Food and Drug Administration (FDA) 510(k) database is an essential resource maintained by the agency that holds records of premarket notifications, known as 510(k) submissions, which are required to demonstrate a medical device’s substantial equivalence to a device already legally mar...
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid 34. Smith AJ, Dieppe P, Howard PW, Blom AW; National Joint Registry for England and Wales. Failure rates of metal-on-metal hip resurfacings: ...
Cardinal Health™ at-Home Consumer Health OptiFreight® Logistics OptiFreight® Logistics Pharmaceutical Distribution Pharmaceutical Distribution SOURCE℠ Generics SOURCE℠ Generics Specialty Distribution Services Specialty Distribution Services Cardinal Health™ Inventory Manager ...
The FDA operates a massivedatabase, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might ...
13-15 The FDA databases were linked to a new predicate medical device database derived by applying an automated text extraction algorithm to public evidence summary documents for 510(k) devices.13 The study was determined to be exempt from review by an institutional review board at the ...
In June 2023, Roche received FDA clearance of its Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) to help clinicians spot early signs of AD. gettyimages-1041685750_640.jpg Drug Delivery Insight (February 2023) Following the initial launch of its G7...
FDAAny article or healthcare product intended for use in the diagnosis of disease or other condition, or for use in the care, treatment or prevention of disease, which does not achieve any of its primary intended purposes by chemical action or by being metabolised. ExamplesDiagnostic test kits...
While there are many handset manufacturers, the only profitable ones at present are Apple, Samsung and Huawei, who are also the top three in unit sales. Manufacturers today are faced with increased complexity brought about by new standards (such as 5G), carrier aggregation, multi-mode phones, ...
The European Database on Medical Devices (EUDAMED) will be mandatory in the future to track all devices placed on the EU market under the MDR, but is still under development. Therefore, we developed the list of devices of interest (Supplementary Table 1) using sources based on FDA records....
On October 18, 2018, FDA published draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.