Injector Failure Guidance From US FDA Aims To ‘Balance’ Reliability And Feasibility

29 Apr 2020

Injectors used for emergency administration of drugs such as epinephrine should be demonstrate a ‘remote probability’ of failure equating to no more than one in every 100,000 injection attempts, agency says in a new draft guidance that may have relevance for other types of emergency-use drug delivery devices.

Woman Injecting Epinephrine Using Auto-injector Syringe As An Emergency Treatment For Allergic Reaction — US FDA is giving guidance to sponsors of emergency-use injectors on demonstrating product reliability. • Source: Shutterstock

A new US Food and Drug Administration guidance on recommendations for demonstrating that injector products will reliably deliver the drug component on an emergency basis could help head off recalls and shortages of injectors that fail to perform as expected in the postmarket setting.

Injectors used to administer drugs on a one-time, emergency basis should be demonstrated to have a “remote probability” of failure...