FDA Releases Proposed Rule on Device Tracking System
On Tuesday, FDA released a proposed rule to create a unique device identification system to track medical equipment. Under the rule, UDI codes would be stored in a public database so regulators, physicians and other entities could monitor safety issues. FDA will accept public comments for 120 days after the proposed rule is published in the Federal Register.
- "FDA Finally Issues Unique Device Identifier Rule" (Goedert, Health Data Management, 7/3).
- "FDA Lays Out Medical Device Identifier System" (AP/Sacramento Bee, 7/3).
- "U.S. Plans IDs To Track Medical Device Safety" (Yukhananov, Reuters, 7/3).