Medical tech industry stakeholders are showing mixed reactions to the FDA’s latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.
Unique Device Identifier (UDI)
The FDA released a proposed rule on its long-awaiting "unique device identifier" system for tracking and monitoring medical technology.
The rule would require most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety.
MASSDEVICE ON CALL — A quartet Senators yesterday introduced the bi-partisan Ensuring Safe Medical Devices for Patients Act, in the latest legislative effort to beef up the FDA’s oversight of medical devices.
Sens. Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.) lent their names to the measure and won the backing of a clutch of advocacy groups.