FDA drafts guidance on emergency-use injector reliability
The US Food and Drug Administration (FDA) this week issued draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening emergency.The guidance specifically applies to emergency-use injectors that are prefilled or co-packaged with emergency drugs or biologics, such as those to treat anaphylaxis, and is intended to expand on FDA’s 2013 guidance Technical Considerations for Pen, Jet, and Related Injectors for Use with Drugs and Biological Products.
“For the patient experiencing the emergency or their assisting lay caregivers, there may be only one opportunity to use the product and for that one opportunity the emergency-use injector needs to successfully inject the drug at that time,” FDA writes.
While noting that both drug current good manufacturing practice (cGMP) and device quality system regulation (QSR) requirements must be met, FDA highlights six sections of the QSR that are “particularly important” for developing emergency-use injectors related to design controls and corrective and preventative actions.
“FDA recommends that emergency-use injectors include design control specifications for successful injection reliability of 99.999% with a 95% level of confidence,” the agency writes, adding that this target is equivalent to one detected failure per 100,000 injection attempts in the postmarket setting.
“This reliability level was found to balance appropriately the objective of ensuring the emergency-use injector performance is as safe and reliable as possible with considerations on feasibility,” FDA writes.
While the FDA-recognized ISO 14971, Application of risk management to medical devices, considers events with a detection rate of one per one million to be improbable, FDA says that with current technology, striving for such a low detection rate “could result in drug shortage or delayed product availability.”
The guidance goes on to provide a model for establishing reliability and recommendations for completing a reliability report to submit premarket submissions for products that rely on emergency-use injectors.
FDA