Hello Everyone,
Can anyone provide me insight on how to track a
reabsorbable implantable synthetic bone graft which is a 510(k) approved (class II) product and no special controls for tracking on FDA clearance letter. 21 CFR part 821 requires a manufacturer of implantable device to track the device "
if the device meets one of the following three criteria and FDA issues an order to the manufacturer: the failure of the device would be reasonably likely to have serious adverse health consequences; or the device is intended to be implanted in the human body for more than 1 year; or the device is a life-sustaining or life-supporting device used outside a device user facility. A device that meets one of these criteria and is the subject of an FDA order must comply with this part and is referred to, in this part, as a "tracked device."
However, I am not sure how a reabsorbable implantable synthetic bone graft qualifies in the above mentioned categories. Any inputs will be highly appreciated.
Thank you,
Best,
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Shubhajit Mitra
Senior RA Specialist
United States
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