Hi All,
If my device is not rated at a voltage and/or frequency than the ones for utility supply in the US, would the test reports still be good for the FDA purpose? In the US could I use a voltage converter inside a hospital for connecting my device? If yes, would I have to include the converter as an off the shelf component in my regulatory submission and would I need to test with the converter included in the test sample?
If I have missed anything please let me know
If my device is not rated at a voltage and/or frequency than the ones for utility supply in the US, would the test reports still be good for the FDA purpose? In the US could I use a voltage converter inside a hospital for connecting my device? If yes, would I have to include the converter as an off the shelf component in my regulatory submission and would I need to test with the converter included in the test sample?
If I have missed anything please let me know