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
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 6-273 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
• 6-278 ISO 11040-5 Third edition 2012-02-15
  Prefilled syringes - Part 5: Plunger stoppers for injectables
• 6-382 ISO 11608-7 First edition 2016-08-01
  Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
• 6-464 ISO 11040-4 Third edition 2015-04-01
  Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
• 6-475 ISO 11608-4:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
• 6-476 ISO 11608-2:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
• 6-477 ISO 11608-3:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
• 6-478 ISO 11608-1:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• 6-479 ISO 11608-5:2022
  Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions

Third Party Review

Not Third Party Eligible