Product Classification

• Device: injector, pen
• Regulation Description: Piston syringe.
• Definition: A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle.The device can be used by health professionals or for self-injection by the patient.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: NSC
• Submission Type: 510(k)
• Regulation Number: 880.5860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 11608-1 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• ISO 11608-2 Second edition 2012-04-01 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
• ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• ISO 11040-4 Second edition 2007-02-01 Prefilled syringes - Part 4: Glass barrels for injectables
• ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 11608-4:2006 Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
• ISO 11608-3 First edition 2000-12-15 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods

Third Party Review

Not Third Party Eligible