UL (Underwriters Laboratories), a global safety science leader, has announced that the US Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 – Standard for Household and Commercial Batteries, and UL 1642 – Standard for Lithium Batteries (Cells).
Consensus standards are standards recognized by the FDA for use in evaluating medical devices before they are approved for market entry. The FDA’s Center for Devices and Radiological Health (CDRH) believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. In the case of medical devices using batteries, manufacturers can now use the proof of compliance with UL 2054 and UL 1642 as evidence of a device’s safety and effectiveness.
According to Ibrahim Jilani, Battery Manager for UL’s Consumer Technology Division, consensus standards are also a means to streamline the premarket review process. “The use of these recognized standards will not only help medical device manufacturers reduce regulatory obstacles to enter the US and international markets but also help them satisfy FDA premarket review requirements.”
Although certification is voluntary, UL anticipates this announcement will likely be a sizeable regulatory driver going forward whereby medical device manufacturers will look to have UL 2054 Compliant Nickel Cell Type(s), UL 1642 Compliant Lithium Cell Type(s), and/or UL 2054 Compliant Battery Pack(s).
“UL has more than 30 years of experience in battery standard development, safety and performance testing, fostering innovation in the industry and boosting confidence in battery quality,” said Jilani. “We believe both medical device manufacturers and consumers will benefit from products evaluated to UL’s battery safety standards in the United States and markets worldwide.”