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FDA Proposes Supply Chain Management Requirements

6 minute read

In response to the global COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) is closely monitoring the supply chain to ensure sufficient availability of critical medical products. In late February, specific proposals were outlined in a statement that would enable the FDA to prevent or limit medical product shortages.

These proposals, included in the 2021 fiscal year budget, include requiring risk management plans, improved data sharing and requiring more accurate supply chain information, and reporting requirements for device manufacturers. Companies can stay ahead of these proposals and better mitigate future supply chain risks by adopting Internet of Things (IoT) technology solutions, such as real-time monitoring and visibility services for in-transit goods and remote assets.

Risk Management

According to the FDA’s statement, “many medical product manufacturers lack plans to assess and address vulnerabilities in their manufacturing supply chain, putting them, and American patients, at risk for drug supply disruptions following disasters.” Visibility into the location and status of your goods and assets allows you to identify and address any gaps or breaches – and lower the risk associated with potential asset damage or loss. IoT solutions provide near real-time, continuous visibility and monitoring of high-value assets.

Accurate Supply Chain Monitoring

The FDA’s proposals also call for more accurate and timely supply chain monitoring. Optimizing an end-to-end supply chain requires the ability to reliably track goods from points of production through storage and final delivery. With various IoT tracking solutions, goods owners can get full visibility into what’s happening to the goods during shipment, and access an entirely new level of real-time shipment control data for key events during transport. This provides automated and accurate data for the entire transportation chain.

Reporting Requirements

The FDA is also seeking to establish reporting requirements for device manufacturers. “Among other things, the FDA proposes to require that firms notify the agency of an anticipated meaningful interruption in the supply of an essential device,” according to the statement. The data collected by IoT asset tracking devices can be used to inform KPIs in the logistics industry – in addition to traditional track and trace data. These KPIs are used to better understand the logistics workflow and help medical device manufacturers improve their supply chain efficiency. Look for print-friendly report formats of conducted transports with historical data to provide a simple way to securely share transport data outside of the company.

Comprehensive Solution

Most goods transportation today lacks visibility and traceability of what happens during shipping. In today’s business climate, the logistics business is no longer just a matter of moving cargo from a to b. Handling, temperature, and punctuality are becoming increasingly important parameters, especially for pharmaceutical and medical device transportation. The FDA is aware of this growing need for supply chain visibility and looking to expand its authority to “prevent or mitigate medical product shortages.”

The KORE Critical Asset Management solution is an advanced, comprehensive solution to visualize and mitigate the risks associated with global, multi-modal supply chain operations. The solution provides enhanced visibility to your goods’ location and condition with real-time GPS location information, as well as data on temperature, shock, and tilt events occurring anywhere around the globe. This not only improves tracking, but it also helps ensure compliance with policies required for chain-of-custody and temperature-controlled supply chains.

The solution includes hardware (for condition at the package level), communications, cloud analytics, and reporting tools as a service. Companies can easily visualize the conditions of the asset in transportation and get early detection of risks (events) that can jeopardize the quality, integrity, and security of the product.

Through early detection (via customizable settings and thresholds per shipment), Critical Asset Management can push notifications so users can take action and immediately mitigate potential risks, as well as certify the integrity of the chain of custody for regulatory and quality requirements. This will be of the upmost importance as the impact of COVID-19 grows, and shortages of medical products such as personal protective equipment become apparent. IoT solutions like Critical Asset Management could prevent further goods to be lost – and ensure our valued medical teams are protected.


There are a lot of ways that IoT solutions can help you mitigate supply chain risk — but first you need to be mindful of the challenges associated with deploying IoT supply chain solutions. In our webinar with experts from Thermo Fisher Scientific and Beecham Research, we discuss how to overcome these challenges.

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