Class I (exempt) testing requirements

A

Amit Bechar

Registered
#1
#1
Hi
Hope to gain some insight.

We intend to import an electric facial massager/exfoliator. (the closest product code for this is: ISA).
To my understanding, as an exempt device we are only required by the FDA to register our facility and uphold GMP guidelines (no 510(k) submission).
However, we are unsure about actual testing (other than FCC related tests).
For example, are we required to perform ISO 10993 biocompatibility testing as risk control under the GMP?
Are there any other standards for which we should take note?

Many thanks
 
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