Comments: Syringe Guidance Unclear, Should Address Luer Connectors

The FDA’s recent draft guidance on glass syringes is unclear and doesn’t address the role of luer connector devices in connectivity problems, several devicemakers and trade groups say. The guidance — which followed a number of safety alerts about problems with glass syringes connecting to certain intravenous access systems — seems to point only to the syringes as the cause, making no mention of problems caused by certain needleless luer access devices, the Combination Products Coalition says.
Devices & Diagnostics Letter