Regulations for Medical Device Kit for Training Personnel?

Q

QualityDean

Registered
#1
#1
My company is designing a training kit whereas all products inside the kit are labeled "Not for medical use." What is our FDA Design Control requirements for this type of kit? It will be marketed and sold to end user who will only be using the kit for training purposes.
 
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Ronen E

Ronen E

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Staff member
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#2
#2
This is likely to be considered "not a medical device", which would make it exempt from all medical devices regulations.

- I would consider changing "medical use" to "clinical use", as the former is a bit more vague. Training medical personnel might be considered a medical use. Clinical use means use for treating (etc.) human patients.

- Intended use (which is what the FDA considers when ruling whether something is a medical device or not) is not determined solely by labeling, so make sure that your org's entire conduct (including sales force verbal statements, website contents etc.) supports a conclusion/impression that no clinical use is intended.
 
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