FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device Identification: Policy Regarding...
GUDID and UDI – Are You Prepared?
The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices (via...Healthcare Insights – 2019 Recap
Happy New Year! As the dust settles from the holiday madness and end-of-year celebrations, we thought we’d take a quick look back and reflect upon our 2019 journey. We’re so fortunate to work with an amazing roster of customers and partners whose relationships are...