EMERGENCY USE AUTHORIZATION AND ENFORCEMENT
FDA RESPONSE TO COVID-19 – INFUSION PUMPS & ACCESSORIES
PUMP SYSTEM EUA
The B. Braun Space and Outlook Pump System has been issued a letter of authorization under the current emergency declaration. This pump system is used by HCPs in tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and for ground medical transport use. Examination of the letter shows that no regulatory requirements have been waived except for UDI. Authorized labeling include the Instructions for use and Fact Sheets provided for HCPs and patients pertaining to the emergency use of the pump system. Further labeling requirements include identification that the device is not FDA-cleared or approved and only authorized for use under and for the duration of the emergency conditions.
In accordance with the FDA guidance regarding infusion pumps, request for EUA should include information on how the following hazardous situations were considered including risk control measures, mitigation strategies, and V&V test reports: Infusion deliver error, air emboli, fluid ingress, power management, remote control, and cybersecurity.
For patients requiring continuous infusion therapy during the COVID-19 public health emergency, infusion pumps and accessories are necessary for care. FDA recognizes the need to help increase adequate supply of devices to treat patients and foster development of technologies to maintain safer physical distance between HCP and patient affected by COVID-19. Changes that do not increase undue risk in FDA-cleared infusion pump devices and accessories will not require premarket notification for the duration of the emergency. Modifications under this policy affect indications, functionality, hardware, software, design, or materials. Expected changes are to address supply chain gaps and increased production capabilities.
Modifications to indications or functionality to expand use environments and patient population, such as use in transportation or pediatrics, respectively, are not thought to create undue risk. Additional remote monitoring and control capabilities also fit within the enforcement policy. However, changes that create undue risk, such as use in a magnetic resonance environment or implementation of physiological closed loop control system, do not apply. Hardware and software modifications required to achieve increased remote monitoring or control also apply for the waiver of 510(k) submission. Cybersecurity measures and controls should be implemented in any hardware or software changes.
Material changes to FDA-cleared pump system components and accessories to provide for alternative or more available manufacturing will not be subject to FDA notification. Infusion pumps are designed to work as a system comprised of various devices such as tubing, filters, and manifolds. Supplier changes to maintain availability may be necessary and require material change. Accessory components that include specific durations of use and shelf-life may be distributed and used past the labeled date if the products would not increase risk.
Changes should be made under design, evaluation, and validation requirements of applicable FDA recognized standards. Verification and Validation testing provided in the FDA guidance for infusion pumps is still recommended as noted above.
COVID-19 Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
Emergency Use Authorization Products, Letters, Authorized Labeling, and EUA Request Templates