Use of 'dedicated' sterilization trays with Class I devices


Inactive Registered Visitor
Greetings everyone,
While sterilization trays themselves are Class II (for FDA), dedicated sterilization trays are often included as part of other Class II devices. The latter approach allows the manufacturer to ship a sterilization tray that is custom designed for specific use with a particular Class II device.
Can someone explain how this scenario changes if a custom-designed sterilization tray (that is specifically intended for use with the said device) is associated with a Class I medical device. Does this change class for the medical device in question? It is taken for granted that the sterilization tray will go through all sterilization validation.
Any and all advise will be much appreciated.


Inactive Registered Visitor
If you don't get a direct answer here, or even if you do, you may want to call up FDA DICE (formerly DSMICA) and ask them. They're a helpline, and they're free.

Sometimes they're also a bit curt, and apparently they have a timer beyond which they have to terminate the conversation so you can't ask many follow-ups, and sometimes they don't know the answer if the question is too arcane...but they certainly can refer you to FDA's subject matter expert.

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