FDA Updates Guidance on Medical Device TrackingFDA Updates Guidance on Medical Device Tracking

FDA has issued an updated guidance document on medical device tracking, superceding one written less than a year ago. The main change is that it adds cultured epidermal autografts to the list of devices that must be tracked. Upon request, manufacturers subject to tracking requirements must produce information to FDA within 3 days about devices not yet distributed to patients, and within 10 business days about ones that have been.