Hello all. I'm new to this forum. I check in from time to time. I'm hoping the brain trust can help with this issue. I have a device in with the FDA on a 510(k) submission. The legally marketed predicate device is made by my company for 14 years. It is a battery operated pain management device like a TENS but not a TENS. We have performed over 400 tests for all areas of development. We conform to many standards and guidance documents. The FDA is asking us to conduct tests on electrical safety. This is where I tell you that the proposed device is battery powered. 4 AA primary batteries. No lithium. No chance for incorrect installation (polarity). No battery charging. No mains power. Hardware limitations such as low inductor values in power supply. No temperature concerns even at max output. Tested every each way except no mains testing because we can't (no mains). BF applied parts are part of the system so we have tested for safe current & touch current. All current tests have been below thresholds. EMC tests are all green.
How do I satisfy Electrical Safety testing requirements when there really aren't any for battery operated devices? I don't know how to reply to the FDA except whine and tell them they are wrong; I hate to do that.
How do I satisfy Electrical Safety testing requirements when there really aren't any for battery operated devices? I don't know how to reply to the FDA except whine and tell them they are wrong; I hate to do that.