Draft Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4; Availability

PDA recognizes the potential risk to patient safety as a result of connectivity problems between prefilled needleless glass syringes and pin activated needle free connecting devices and appreciates FDAs efforts to address the risk with this draft guidance. PDA is not aware of a more general issue affecting connectivity between syringes conforming to ISO 11040-4 and standardized ISO 594-2 conical Luer Lock fittings. Therefore, PDA recommends that FDA limit the scope of this guidance document to the more specific topic of connectivity with pin activated needle free connecting devices and that the guidance strike a balance between modifying the syringe tip to fit the pin activated needle free connecting devices and modifying the pin activated needle free connecting devices to fit the syringe. The attached comments and proposed changes were developed to focus the guidance on this specific patient safety concern.