CMC


FDA:Dates of compliance with UDI


The FDA will provide a policy of discretion for Class I and unclassified products in order to extend the UDI compliance dates of the lower-risk medical devices. This policy includes the following:
- compliance for labeling
- GUDID data presentation
- standard date format
- direct mark requirements
This discretionary policy will not apply to Labellers who meet UDI requirements.


What are the benefits of the UDI (Unique Device Identification System)?
- Accurate reports, with reviews and analysis to identify and solve the problems of products faster
- Identify a device faster and more accurately and obtain information to reduce medical errors
- Improve the analysis of devices in the market by clearly documenting information related to the product
- Allows manufacturers, distributors and healthcare facilities to manage more effectively medical device withdrawals by providing a standardized identifier
- Identify counterfeit products and prepare for medical emergencies by providing a global and secure distribution chain.
- Develop a recognized medical device identification system