Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff

Issue Date: June 7, 2013
Issued by: Center for Biologics Evaluation and Research
Topic(s): Administrative / Procedural, Combination Products
Status: Final

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff

FDA is issuing this guidance document to describe the technical and scientific information that FDA expects in a marketing application for a pen, jet, or related injector device that is intended to be used with a drug or biological product. For purposes of this guidance, the term injector includes, but is not limited to: jet injectors, pen injectors, piston syringes, needle-free injectors, mechanically operated injectors, and injectors with computerized or electronic elements.

Download the Guidance Document