FDA Publishes a Draft Guidance on the Premarket Notifications 510(k) Protocol for Today’s Medical Devices

August 15, 2014

The Food and Drug Administration (FDA) recently issued a new draft guidance on premarket notifications 510(k) approval protocol that outlines information on the various benefit and risk factors to consider when determining whether a medical technology is substantially equivalent to a legally marketed device based on its technological features. With the information provided in the FDA guidance on 510(k) submission, manufacturers can easily align their products to the industry safety standards.

FDA Publishes a Draft Guidance on the Premarket Notifications 510(k) Protocol for Today’s Medical DevicesOne of the medical devices subjected to substantial equivalence determination is the infusion pump. The IV pump system has two types: the externally-powered stand-alone unit used for intravenous delivery of medications in a hospital setting; and the compact battery-powered device designed for ambulance or helicopter use.

These two IV drug infusion devices are employed in entirely different settings, power-driven by different sources, and offer different levels of reliability in drug administration. In this case, it has been found that most manufacturers opt to have their devices FDA-approved through the 510(k) process instead of going through the more painstaking and expensive Premarket Approval (PMA) process.

Considering the evaluation of infusion pump systems, the FDA emphasizes the risks more than the benefits of the technology applied in the medical device. As such, FDA aims to encourage medical device manufacturing companies to take the initiative in alleviating the risk factors to gain 510(k) clearance and the approved device as “substantially equivalent.”

The newly issued FDA guidance also focuses on the importance of the premarket review process, whereas the predicate device or the optimized version of the traditional medical device is required to undertake a more rigorous PMA process and then evaluated in contrast with the newer medical product in terms of safety and effectiveness.

Patient safety is paramount in the healthcare and biomedical technology arenas. Medical device manufacturers should focus on addressing the need for safe and effective medication and equipment more than the pharmaceutical and medical technology industry’s need for speedy product clearance. AIV is committed to providing clinical-grade refurbished IV pumps, replacement parts, accessories and repair services for major infusion equipment manufacturers.

Browse through AIV’s full spectrum of infusion pump products and services at www.aiv-inc.com/iv-infusion-pump-replacement-parts.html today for more information.

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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