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# Questions on Emergency-Use Injector Guidance
- URL: https://www.fdaweb.com/questions-on-emergency-use-injector-guidance/
- Published: 2020-06-25T12:00:00.000Z
- Updated: 2026-09-14T16:19:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147093

The Association for Accessible Medicines and Teva have raised identical questions and issues about an FDA draft guidance on technical considerations for demonstrating the reliability of emergency-use injectors submitted under a BLA, NDA, or ANDA. The [company](ttps://www.regulations.gov/document?D=FDA-2019-D-5573-0013) and [association](ttps://www.regulations.gov/document?D=FDA-2019-D-5573-0009) raise these issues: 

- FDA needs to come to a reasonable definition of “emergency-use” because the testing the agency describes in the guidance is rigorous and challenging and likely would not be appropriate for some, if not most, products;
- the possibility that FDA would create a different standard for devices considered under an ANDA than the agency used in reviewing devices when they were originally approved under an NDA;
- the arduous nature of the testing described in the guidance could discourage sponsors from innovating and updating device design attributes; and
- the need for FDA to align the occurrence of a device failure with the possibility that harm will be experienced by the device user or patient as a result of the failure.

The two letters also contained technical line-by-line comments. Pfizer submitted a [chart](https://www.regulations.gov/document?D=FDA-2019-D-5573-0015&ref=fdaweb.com) with only technical comments.