Hi robyn
Sounds like two main questions here. One on defining roles and responsibilities, and one on classifying a device/kit intended for preparing some kind of oral appliance?
For the first, it might be a good idea for the service provider to make an agreement with the contract manufacturer, defining a shared understanding of the areas that could look gray.
If the contract manufacturer is registering their own UDI for the kit, it seems they are identifying themselves as the responsible manufacturer, in which case the service provider would simply be filling a distributor role. (The customer may have asked the manufacturer if they could provide a certain product and the manufacturer agreed to develop and supply it.)
Who is writing and validating the instructions for use? If that's the service provider, they may be filling the specification developer or relabeler role, in which case they'll register as a manufacturer. (Or they may be providing a labeling development service for the manufacturer.)
Whose contact information will appear on the label? The label will need to identify a company and its role as manufacturer, specification developer, or distributor. (Like "manufactured by X", "manufactured for X", or "distributed by X")
Who will be handling any complaints received?
Who is keeping the DHF for the kit?
What are the responsibilities of the service provider and the contract manufacturer if any of the kit components are recalled?
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 06-Nov-2020 20:54
From: robyn woidtke
Subject: specification developer, distributor or ?
Hello:
I have a conundrum. I help with a company that is a service provider to dentists, i.e. a dental service organization (not a manufacturer). They want to provide a home teeth impression kit (not for aligners) for other oral appliance. They want to use the kit in conjunction with a home teledental visit. The kit has all class 1 products, except for the putty, which is class II (US), class I Canada. I would classify as a convenience kit.
The service provider has specified to the contract manufacturer what contents they want, how packaged etc....in the impression kit. The kit has UDI from contract manufacturer. The kit is not specifically branded to the service provider. The service provider sends the kit to the patient on the Rx of the DDS, after the impressions are done, the impressions are sent to a dental laboratory.
I know Smile Direct, Byte and Candid (and others) have similar product, i.e. home teeth impression kits for aligners, the process is essentially the same. A citizen petition was lodged by the ADA for an injunction, but was denied by FDA per 21 CFR Part 10.30 . I have yet to find an actual 510k for a home teeth impression kit (if anyone can help :)) , the components i.e. putty have a 510k, but the impression trays are class 1 exempt. I have looked through the convenience kits guidance documents (one from 1997 [these types of kits are not listed] and the newer UDI). I was able to locate a kit on GUDID, but funny enough, for the question of kit, it says no, although the device name states home teeth impression kits. But which lists the K# for the putty, but not a kit itself.
It is a big ask, but if anyone has suggestions for this situation, I would be grateful.
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robyn woidtke
Castro Valley CA
United States
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