Description
FDA has recognized International Organization for Standardization (ISO) Standard 11040-4 for glass syringes that are intended to deliver drugs or biological products.2FDA has become aware of adverse events and product quality events related to connectivity problems when certain glass syringes are used with connecting devices, including connecting devices that conform to the FDA-recognized ISO 594-2 standard. "Connecting devices" include needles, needless luer connectors, adapters, and transfer units. Accordingly, FDA has determined that, for glass syringes, demonstrating conformity with the ISO 11040-4 standard alone does not ensure that the glass syringe can be properly connected to connecting devices. Therefore, this guidance identifies additional, technical information that should be submitted by sponsors who seek to rely on conformity to ISO 11040-4 for a glass syringe product.
Scope & Applicability
Product Classes
3marketed for general use under a device premarket notification
Devices intended for delivering drug and biological products.
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
3Entity responsible for submitting applications under section 524B
The entity responsible for responding to SLC notifications and orders.; Entity responsible for submitting labeling supplements or rebuttals; Entity responsible for submitting labeling supplements and appeals
responsible for addressing deficiencies in the master file
Regulatory Context
Attributes
3Undefined dimension in ISO 11040-4 for syringe nozzles.
Dimension lacking specification in the glass syringe standard.
Single mode of action expected to make the greatest contribution to therapeutic effects
Identified Hazards
Hazards
3Issues when glass syringes are used with connecting devices.
Physical failure of the device during injection.
Risk of inappropriate administration of extra doses
Related CFR Sections (2)
- 21CFR880.5860§ 880.5860 Piston syringe.
(a) Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is usedRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (10)
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See Also (8)
- Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff (Status: Final)
- Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff (Status: Final)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)