Implications of an import detention

[mr.mike]

Wondering if someone can guide me to the appropriate FDA regulations and/or guidance documents that describe the implications of an FDA import detention.

Obviously, this means you are no longer permitted to sell to the US (at least until things are resolved and ban lifted).

But what I'm wondering is how it affects devices already sold. Specifically:
- Can we still service devices previously sold?
- Can we continue to issue field corrections (e.g. push software updates) for devices previously sold?

I'm curious to learn more. Any guidance much appreciated.

MM

 

[MIREGMGR]

If you don't successfully resolve the detention problem, and if FDA decides that the reason for the detention applies similarly to previously marketed units, FDA might escalate to a recall.

This is no different for an import situation than for any other context in which a regulatory non-compliance comes to FDA's attention. If you don't satisfactorily resolve the situation, they may escalate. A recall of already-marketed units of the same product is an escalation step.

The traditional thinking is that, if you conclude that FDA is about to order a recall, it's less damaging to your customer relationships and market reputation to voluntarily initiate a recall on your own, arranged through your region's Recall Coordinator, of course. A "voluntary" recall also may have a less onerous endpoint-condition.

Yes, you can continue to service and support prior-sold units, unless/until FDA orders otherwise.

Directions for FDA personnel in regard to import operations are found in Chapter 9 of the "FDA Regulatory Procedures Manual", http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.

 

[mr.mike]

Thanks MIREGMGR.

For the purposes of my inquiry, I'm ruling-out recall of previously sold devices. The devices in question here are low-quantity and low-risk, even in the most extreme cases of malfunction or quality problems (which, btw, we never seen an unanticipated number of complaints).

Anyway, my concern regarding servicing existing devices is the fact that they will have to be shipped outside the US to the servicing facility. I'm concerned that if there was an import detention that the units would not be able to be returned to the customer in the US after servicing.

 

[MIREGMGR]

...my concern regarding servicing existing devices is the fact that they will have to be shipped outside the US to the servicing facility. I'm concerned that if there was an import detention that the units would not be able to be returned to the customer in the US after servicing.

Yes, that scenario certainly could occur if Customs detected what was re-entering and checked the database for status. I'm not aware of any exception on the entry condition rules for already owned units that are being returned to USA after service.