30 Day Trial

ORTHOWORLD » Other Articles of Interest

FDA Extends UDI Deadlines Following Database Security Issues

FDA has extended the upcoming deadline for compliance with labeling and data submission to the Global Unique Device Identification Database (GUDID) due to the Agency pulling the database offline after an undisclosed security vulnerability was detected. 
 
Manufacturers of implantable, life sustaining and life supporting devices, as well as Class III devices that received extensions expiring between August 7 and the original September 24 deadline, now have until October 24 to submit data. 
 
In May, FDA launched the database that will house submitted data from medical device companies. The database allows the public to track medical devices from manufacturing through the supply chain to patient use.
 
UDI compliance best practices and the remaining deadlines can be found in the article, “UDI Implementation: Your Next Steps.”
 

0 COMMENTS

Name
Comment