GMP: FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

In September 2014, we reported about the FDA guidance draft on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Now, on 17 August, the FDA published the adopted version of that guidance document. The FDA developed this guideline related to the prevention respectively the weakening of future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized in the anterior segment of the eye following intraocular surgery. Former TASS outbreaks have been associated with endotoxin. This guidance provides recommendations for endotoxin limits, especially for devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments, because they can be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes.