FDA Wants Proof of Reliability for Emergency-Use Injectors

The FDA said sponsors of emergency-use injectors should include details in their marketing applications to show that the devices are reliable.

In a new draft guidance, the agency also said developers should consider the force required to remove a product’s packaging and the force needed to initiate the injection mechanism in an emergency.

For injectable drug or biological products, it is “essential to ensure that the emergency-use injector will reliably deliver the drug as intended,” the agency said.