Federal Register Notice: FDA is making available a draft guidance entitled Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting PMAs or 510(k)s for different categories of IODs to mitigate future outbreaks of TASS. To download this guidance, click here. To view this notice, click here.