Tuesday 1 September 2015

Endotoxin Testing Recommendations for Single -Use Intraocular Ophthalmic Devices

FDA has issued a new guidance document of interest, titled "Endotoxin Testing Recommendations for Single
-Use Intraocular Ophthalmic Devices."

The introduction reads:

"This guidance document was developed to notify manufacturers of the recommended endotoxin limit for the release of intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories in an effort to mitigate future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized to the anterior segment of the eye following intraocular surgery. It has been associated with significant decreases in vision and may require additional surgical procedures, including corneal transplants and glaucoma surgery, to resolve some of its sequelae.  National outbreaks of TASS have been associated with endotoxin. Devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories, can potentially be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions for different categories of intraocular devices to aid in the prevention of future outbreaks of TASS. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required."

The guidance can be accessed here.

Posted by Tim Sandle

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