March 8, 2023

That Advisory Notice Might be a Recall

I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected.  The answer is yes, but with great care.  Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly can advise affected parties, like user facilities, to immediately quarantine the product while an investigation and risk assessment are underway.  But I’ve seen some prominent multinational medical device corporations advise to be VERY careful and aware that such a quarantine instruction and field action could be automatically considered by FDA to be a recall.

This seems in part to be because such a quarantine-and-investigate action could meet the “removal” and “inspection” qualifiers in FDA’s recall definition when paired with a scenario where the underlying basis for such an action is consistent with FDA’s triggers/criteria for “recall”.  In other words, FDA can consider firms to have initiated a recall even if the firm doesn’t realize it at the time.