Material for laboratory use or Medical Device?

[DMLqms]

Hello all,

A company has been supplying materials for lab-use and have been classifying them as Class I under the MDD.

It's a plastic that is used to make a specific 'prescription' device for a single patient, for tooth straightening/alignment.

I'm thinking that the material isn't a medical device - or - does it become a device due to the intended purpose?

Any clarity appreciated.

 

[shimonv]

The information you provided is not so clear...

As a general guideline: materiel becames a medical device when you are supplying a finished device which meets the definition of a medical device.

 

[ScottK]

From the description it sounds like a component of a device, not a device itself.

"CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.” For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing. When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device. "

Source: FDA's Medical Device Accessory Guidance | Registrar Corp

Is it listed as a device with the FDA? Or does your organization just control it like it's a device?