FDA Issues Final Regulations for Medical Device Tracking Codes

The Food and Drug Administration has released a final rule to begin requiring medical device manufacturers to include unique tracking codes on medical devices.

The use of unique device identifiers is intended to improve patient safety by allowing FDA regulators to track devices on a unit level and recall defective products more easily.

The UDIs will be phased in over the next seven years, beginning with high-risk devices like pacemakers and artificial joints.

More Articles on FDA Regulation:

Michigan Bill Calls for FDA Regulation of Medical Apps
The Case for Integrated Clinical Decision Support Software in EMRs
FDA: How to Use Radio-Frequency Wireless Healthcare Devices 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars