FDA self-injection guidance: Enhancing safety, dosing accuracy and patient compliance

Last June, FDA issued new recommendations for both industry sponsors and for FDA Staff on injection devices—Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biologic Products. [1] As its title indicates, this Guidance discusses the procedures for assessing the technical feasibility of proposed products (either drug-device combinations or medical devices), such as drug-material leaching and extractables, or dose-metering accuracy and the importance of human factors engineering related to combination products. This includes assessing the risks of use of the intended drugs/biological products delivered with the injector and the human factors characteristics of the patient populations using the intended drugs/biological products (p. 13).

To demonstrate that a user can safely and effectively use the injector, comprehensive evaluations of all use related risks and tasks are conducted to ensure the usage requirements of a device are within the natural ability of patient populations. Depending upon the characteristics of the injector, its intended user population, and the environment of use, the studies should focus on essential aspects of using the product.

These aspects may include, for example, the ability of users:

• To read, understand and follow instructions;
• To adequately set up the injector;
• To reconstitute injectable materials, draw up or set the proper dose, prime the injector (if required);
• To perform the injection or self-injection correctly; and
• To dispose of sharps and other disposable materials safely and properly (p.23).

A 2011 draft document, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, provides additional guidance, in this case for all types of medical devices, not just injection devices. [2] Recommendations include testing and validation by patients themselves, as well as taking patient characteristics, such as age and medical condition, into consideration.

References

[1] www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf [2] www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm259748.htm