W
Waterman956
I have been reviewing and attending seminars on the new UDI requirements. Fortunately we are a class II device so we have 3 years from the date of final approval of the rule, expected (by congress) May 2013.
This seem to be fairly complex especially for companies who have multiple locations around the world and/or a large number of products. It will take top level planning, strategy and lot of data checking.
The UDI number will tie the device PMA/510k, listing number, establishment registration number and eventually post market information about the device.
UDI numbers will also need to be updated periodically as a result of a regulatory event.
It will be important to get this all right or could be a very bumpy road, not to mention an incorrect UDI could be considered an adulterated device by the FDA.
So I would like to open a thread for people working on this to share thoughts, ideas and problems in countered.
Remember the "Comment Over" date for the draft rule 21 CFR Part 830 in November 7, 2012. Congress is urging for the final rule by May 2013
This seem to be fairly complex especially for companies who have multiple locations around the world and/or a large number of products. It will take top level planning, strategy and lot of data checking.
The UDI number will tie the device PMA/510k, listing number, establishment registration number and eventually post market information about the device.
UDI numbers will also need to be updated periodically as a result of a regulatory event.
It will be important to get this all right or could be a very bumpy road, not to mention an incorrect UDI could be considered an adulterated device by the FDA.
So I would like to open a thread for people working on this to share thoughts, ideas and problems in countered.
Remember the "Comment Over" date for the draft rule 21 CFR Part 830 in November 7, 2012. Congress is urging for the final rule by May 2013
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