The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has published a report providing an update of its plans to require that most medical devices distributed in the U.S. carry a unique device identifier (UDI).
The CDRH's objective for the UDI rule is to facilitate the clearance and approval of new medical devices or new uses for them, to streamline the dissemination of information about medical devices, to reduce the costs of medical device postmarket surveillance, and to be able to rapidly identify potential safety issues.
The report, titled "Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps," describes the FDA's intended framework and implementation plans, which include an online device registry. Click here to read the full report.
