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# Draft Guide on Injector Technical Considerations
- URL: https://www.fdaweb.com/draft-guide-on-injector-technical-considerations/
- Published: 2020-04-21T12:00:00.000Z
- Updated: 2026-09-14T16:12:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146609

*Federal Register* notice: FDA has made available a draft guidance entitled “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.” The document focuses on emergency-use injectors marketed with the drug/biological product as a prefilled single entity combination product or as a co-packaged combination product assigned to CDER/CBER. The guidance defines reliability as the probability that the injector will perform as intended, without failure, for a given time interval under specified conditions. It also describes information and data that FDA recommends be included in marketing applications to demonstrate that an emergency-use injector is reliable, including the details of an example of an acceptable approach for the mathematical model, statistics, fault tree analysis, and use of certain current good manufacturing practice requirements for combination products to establish reliability of the emergency-use injector. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-08466.pdf?ref=fdaweb.com).