Q: We just had a product recall outside of the United States. What are the implications with FDA — are we required to notify the Agency about a non-U.S. product recall?
A: Technically, no. But you definitely should be prepared to answer questions if they arise from FDA.
Here’s why: If you look at FDA’s product recall rules and definitions and, more importantly, FDA’s expansion of those definitions through enforcement actions, the Agency may take the position, “Even though you recalled that particular model outside of the U.S., you’ve got a very similar device being sold here. Why wasn’t that one recalled?”
The days of being able to do things within limited geographical boundaries and not having FDA know about them are gone. If you conduct a recall in a country that belongs to the group of National Competent Authorities, the regulatory body in that country will immediately send a National Competent Authority Report (NCAR) to other regulatory bodies around the world.
“The days of being able to do things within limited geographical boundaries and not having FDA know about them are gone.”
For example, if you conduct a product recall in Spain, FDA likely will know about it within hours because the Agency will receive an NCAR report from the competent authority in Europe.
A few years back, we worked with a company that conducted a very limited recall in a non-U.S. country where its national authorities forced the recall. Our position was that the recall was not scientifically warranted, but the authorities wouldn’t budge.
As a result, what started out as a small local recall turned into a global recall within 24 hours. That’s because the NCAR report was sent to FDA and Health Canada, who both picked up the phone and started asking questions.
FDA, like other governing bodies, doesn’t want to be embarrassed or be seen in a situation where another national authority has taken action, but it hasn’t.
So the chances are high that FDA is going to ask you to explain why you’re not doing a similar recall in the U.S.
Don’t be caught by surprise — anticipate the potential for FDA and others to raise questions even if the recall is outside their jurisdiction.
Answered by the staff of EduQuest. For further information and training on FDA’s medical device regulations, plan to attend EduQuest’s QSR Compliance Basics: Complying with FDA’s 21 CFR Part 820 Quality System Regulation.