Drug, Biologic Injector Rules Clarified in Final Guidance

An injector’s intended use, technical characteristics and proposed labeling and packaging can mean the difference between filing a marketing submission with CDRH or the FDA’s drug or biologics center. In a newly issued guidance, the agency aims to clarify the varying regulatory pathways for pen, jet or related injector devices intended for use with drug and biological products, focusing on scientific and technical considerations companies should weigh when developing the combination products.

The document, Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, finalizes a draft version published in April 2009. Comments received on the draft resulted in some changes to the final version, the FDA says. For example, the agency clarifies its rationale for its technical and scientific recommendations for the three basic groups of injectors.

The final document provides considerations applicable to all injectors. But it also provides general content and format information for injectors that are reviewed under 510(k) submissions, or alternatively under a new drug application or new biologic licensing application for the combination product.

Typically, general-use injectors would be submitted to CDRH via the 510(k) pathway. The application should include information such as:

• The 510(k) number of the predicate;
• Indications for use for the new injector;
• Injection sites;
• Depth of needle insertion, if applicable;
• Injector life;
• Dose and ways to determine dose accuracy; and
• Performance specifications, such as injection force and pressure.

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