Is Device Tracking Card an actual requirement under FDA regulation?

J

Jen

Starting to get Involved
#1
#1
Hi. So, a little bit of the background..the company I work for sells a class II Implantable medical device. A Device Tracking Card is always inserted in the device packaging. The hospital supposedly fills the Device Tracking Card with information such as hospital name, date, physician name and procedure, etc. And the Device Tracking Card should be mailed back to us. But nobody does that over the years.

Recently, I have tasked to revise all the labels. I searched all over the internet but cannot find any requirement/regulation related to Device Tracking Card. When I asked the seniors in my company, the answer I got is the consultants include this Device Tracking Card when they set up the quality system years ago. And the Quality System supposedly complies with FDA regulation.

I got the feeling of the Device Tracking Card is no an actual requirement and incline to remove the Device Tracking Card from the labelling. But I also worry that I have overlooked the requirement. I hope someone here can confirm my suspicion or correct me. Many Thanks!

:thanx:
 
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