The FDA’s Center for Devices and Radiological Health (CDRH) has limited authority to require that device makers provide notice of current and impending device shortages. Nonetheless, CDRH has several administrative tools at its disposal to support this effort, aiming to ensure that patient safety is never compromised by device availability issues.
In the first part of this blog, we described the FDA’s declaration that it would seek congressional authority to require device
makers to report shortages under all circumstances. Currently, device makers are legally required to make such reports only during public health emergencies. This regulatory responsibility is described in a recently updated guidance issued Jan. 7.
The FDA’s Office of Supply Chain Resilience (OSCR) plays a key role in ensuring that the risk of device shortages is minimized, and that a shortage is optimally managed when it occurs. There are several mechanisms by which OSCR handles this task, including the development of a Critical Medical Device List (CMDL) that helps ensure that patients do not suffer due to an interruption in the availability of a medical device.
OSCR’s mission is to sustain supply chains by proactively monitoring for vulnerabilities that could lead to shortages. The two OSCR offices are the Division of Prevention, Innovation and Resilience (DPIR) and the Division of Shortage Assessment and Product Authentication (DSAPA). Among the DPIR activities is the development of partnerships with other U.S. government agencies as well as with international entities. These activities serve to improve communication about potential shortages and to promote coordination that will minimize the impact of shortages on public health.
The task of DSAPA is both assessing the prospect of a shortage and preventing counterfeit devices from reaching patients in the U.S. As is the case with DPIR, DSAPA seeks to foster partnerships across the spectrum both internationally and domestically. However, DSAPA also lists regulatory mitigations as one of the tools in its armamentarium.
The CMDL was formed in 2021 when President Joseph Biden issued Executive Order 14001. This order required government agencies and device manufacturers to coordinate their efforts to ensure supply chain resilience during the COVID-19 pandemic. A task force formed to help manage the CMDL had established several criteria for whether a device should be on the list, such as devices that sustain life or are necessary to address medical emergencies. This criterion also requires that the lack of the device or alternatives could lead to serious injury or death of patients.
A second criterion is that the device would be the subject of elevated demand due to an emergency, while the third criterion is any device intended for special populations, such as children, pregnant women, or anyone with disabilities. These criteria are subject to a review for potential updates every three years, although out-of-cycle updates may also be invoked as circumstances warrant.
The September 2023 CDRH report on the CMDL provides a list of the organizations taking part in the task force, and includes manufacturers, distributors, and medical associations. In addition to the FDA, representatives of other agencies, such as the Centers for Disease Control and Prevention, also serve on the task force, in some instances on a consultative basis only.
The task force had considered more than 200 potential devices for inclusion on the CMDL list, but only 142 of those were deemed critical. The justifications for inclusion and exclusion varied by both device type and purpose. Devices that qualify as capital equipment, such as high-end medical imaging systems, do not appear on the list because of the timelines needed to manufacture and install them. Consumables, such as reagents used for in vitro diagnostics, are subject to rapid depletion and can be rapidly manufactured and distributed, and consequently may appear on the list.
Whether Congress will provide the FDA with authority to require device supply chain reporting outside of public emergencies is impossible to predict. Nonetheless, the agency is intent on doing what it can to manage shortages, an objective that industry has clearly agreed is essential for patients now and in the future.
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