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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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0179
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0179.

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