Rx-360 Summary of Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

The final guidance replaces draft guidance issued in April 2009 and is from CDRH, CDER and CBER and Office of Combination Products. The guidance describes the information that is to be included in a marketing application where an injection device is used with a drug or biological product. The guidance is divided into three sections: Scientific and Technical Considerations, Content and Format Considerations, and Where Can I Find Additional Detail? The second and third sections take up only 2 pages of the 29 page guidance, with the primary focus on scientific and technical aspects that should be addressed with the regulatory filing.

The Scientific and Technical Considerations includes but is not limited to

• Description: This includes identification of the “injector” indication for use, conditions of use and description of the drug/biologic.
• Design Features: This includes comparison to existing “injectors”, engineering drawing and photos, dose setting and administration, graduation marks and fill lines, visual inspection of the drug or biological product, safety features, human factors design.
• Materials used in the “injector” construction that should address possible leachables and extractables, adsorption of the drug/biological to surfaces, seal integrity and materials corrosion.
• Performance testing general use considerations including biocompatibility, shelf life stability and expiry dating, environmental conditions for use, functional testing.
• Performance Testing with regard to the injector and drug/biological including: dose accuracy, depth and route of injection, and special testing considerations (including extractables and leachables, adsorpables, container closure integrity and specific expiry dating).
• Clinical Considerations in Performance Testing.
• •Sterilization and Sterility Assurance.
• •Cross contamination potential.
• •Labeling.

To view or download the guidance, click here