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GUIDANCE DOCUMENT

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products Guidance for Industry and FDA Staff June 2013

Final

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

Issued by:
Guidance Issuing Office
Office of Combination Products
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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. 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.