On September 21, 2016, the Food and Drug Administration (FDA) issued a standards-recognition notice (Recognition List #45) that includes ANSI Z80.36:2016 American National Standard for Ophthalmics – Light Hazard Protection for Ophthalmic Instruments. The ANSI Z80.36-2016 was recognized as the US national deviation from the existing standard, ISO 15004-2 First edition 2007-02-15 Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection.
FDA recognition of ISO 15004-2:2007 will be superseded by recognition of ANSI Z80.36:2016. The FDA will accept declarations of conformity, in support of premarket submissions, to ISO 15004-2:2007 until March 31, 2018. After this transition period, declarations of conformity to ISO 15004-2:2007 will not be accepted. Sponsors using ISO 15004-2:2007 in their premarket applications through March 31, 2018 should be aware of the differences between ISO 15004-2:2007 and ANSI Z80.36:2016, and should understand whether these differences could affect aspects of safety and performance for their devices.
ANSI Z80.36:2016 contains new requirements that are absent from ISO 15004-2:2007. If the new requirements apply to a particular device, a sponsor choosing to conform to ISO 15004-2:2007 should be prepared to address FDA questions related to those new requirements.
The FDA regularly updates the list of national and international voluntary consensus standards recognized for use in satisfying portions of device premarket review submissions or other requirements. If you have any questions about these standards, please contact the CDRH Standards Program at CDRHStandardsStaff@fda.hhs.gov .