FDA Issues Assurance Case Guidance for Infusion Pump Manufacturers

December 19, 2014

The Food and Drug Administration (FDA) recently issued the guidance document entitled “Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff”, which aimed to assist infusion pump manufacturers validate safety claims in 510(k) premarket notification submissions. To ensure that critical aspects of infusion pumps are addressed, FDA has developed this document to reinforce product quality and alleviate serious product recalls.

The document further explained that adverse events and infusion pump recalls can be avoided through sufficient design verification and validation processes. By constructing your safety case in concert with the device will not only allow for better safety controls, claims, arguments, and evidence, it may reduce the costs of retrospective mitigations if it is determined that a finished design is not adequately safe.

The FDA proposed the use of safety assurance cases along with the infusion pump 510(k) applications to probe potential recalls and avert health and safety risks. The safety case is comprised of a statement about a property of the system or subsystem, arguments on the hazards caused by the device, and scientific facts and analysis demonstrating the validity of the argument. Furthermore, this report provides evidence on the determinations of medical device’s substantial equivalence.

The use of infusion pumps has been recognized as a smart option for reliable medication delivery. Equipment manufacturers must develop safety case structures for infusion pumps to deliver exceptional patient safety and care. AIV is dedicated to providing high-quality IV pump parts, accessories and repair services that meet clinical safety and workflow goals. Learn more about our extensive line of infusion pumps and services at www.aiv-inc.com/iv-pump-parts-service.html today.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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