Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products," dated June 2013. The final guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title dated April 2009 and published under Docket No. FDA-2009-D-0179.