Question around whether any other labeling regarding batteries is required other than the UL1642 shipping label on the outside packaging. I've looked through 21CFR Part 801 and Device Labeling Guidance #G91-1 (1991/2018) and the most battery labeling information is in 21 CRF § 801.422 Prescription hearing aid labeling.
Some information:
Some information:
- Product is a Class II using a rechargeable Li-ion battery that meets UN38.3 and complies with UL 1642 and UL 2054.
- The battery will be shipped preinstalled and is not intended to be removed/replaced by the user.
- The directions for use will include information such as how to recharge the battery and expected battery life are included.
- Does the outside packaging need to indicate the battery type, number of batteries and that it is pre-installed?
- Are there other guidances/standards to reference in regards to battery labeling?
- Are there best practice or standard wording/labeling that is used (if there are not defined standards)?