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Do you think FDA is going to continue to inspect dental laboratories?

FDA allows dental laboratories with certain business models to be exempt from registration. However, if your business model includes importing, the manufacture of sleep apnea devices or snore guards, repackaging or relabeling of Class II devices such as alloys, porcelain or other Class II medical devices, then you must register with FDA. Upon registration, FDA places you into “inventory” for inspection. There are many inspections that we have not been privileged to, however, the ones that we are personally aware of include importers, repackagers/relabelers, and contract manufacturers of sleep/snore devices. I suppose this means that FDA is making the round of all dental laboratories that are registered with them.

Here are some of our observations from dental labs in the US and other countries that have been inspected by FDA. An inspection can last from 45 minutes to weeks. The most common length of time seems to be 4 days. The other most common observance is that FDA just doesn’t quite understand what dental laboratories manufacture. This presents a problem when the FDA inspector begins using the FDA’s inspection guidance document for medical devices and starts asking the lab owner for documentation that the lab owner is unfamiliar with. The main problem here is that the lab owner doesn’t understand the FDA terminology regarding quality system requirements, therefore, they may have the information but don’t know what to pull out to show the inspector. If the inspector is a “nice guy” he/she will explain, but that’s not always the case.

It’s most likely that FDA will continue to inspect dental laboratories, both domestic and foreign, to ensure compliance with the Quality System Regulation and that dental devices manufactured for patients in the US are safe and effective.

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