Battery Labeling Requirements


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:
  • 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)?
Any other considerations or gotchas? Thank you in advance.
Top Bottom