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FDA does not explicitly define raw material, but depending on your situation, you may actually be looking to use the term component. 21CFR820.3(c) defines component:

Component means 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.

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Q: What is the definition of a Raw Material according to the FDA?
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