FDA Releases Medical Device Data Through a New Open Access Data Website - Infotehna

abernard102@gmail.com 2015-05-12


"The US Food and Drug Administration (FDA) is opening up one of its vast treasure troves of data to the public in the hopes of improving the way medical devices are integrated into the healthcare delivery system. The latest release involves data related to FDA's unique device identification (UDI) program. The program, established by regulation in September 2013, requires most medical device manufacturers to affix identifying information to each device they manufacture. The information is intended to help regulators and companies track and trace their devices more easily ... While the UDI is somewhat useful on its own, regulators have long claimed its real potential will be unlocked when the information is tracked using FDA's Global Unique Device Identification Database (GUDID), which is set to act as a repository of information on the devices. FDA's longstanding goal has been to allow healthcare providers and healthcare delivery systems to link up with its GUDID system, allowing for a transformation in the way care is delivered to patients. For example, a doctor might scan a device code before using a device on a patient, allowing the doctor to see if the device has been recalled, how many devices are supposed to be in the package, whether the device has been discontinued, if the device is safe for use in a MRI machine and to confirm that they have the right device in hand ..."



From feeds:

Open Access Tracking Project (OATP) » abernard102@gmail.com


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Date tagged:

05/12/2015, 07:20

Date published:

05/12/2015, 03:19