On January 6, 2025, the U.S. Food and Drug Administration (FDA) released its final guidance titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” This landmark regulation sets mandatory expectations for manufacturers to notify the FDA when they anticipate any disruption or cessation in the production of medical devices critical to public health, especially during declared public health emergencies.
This rule is a culmination of the agency’s ongoing efforts since the early stages of the COVID-19 pandemic, when critical device shortages such as mechanical ventilators, PPE, infusion pumps, and dialysis components crippled care delivery across the U.S. The pandemic exposed deep vulnerabilities in the surgical supply chain, notably the absence of real-time data on disruptions and dependencies among medical device producers. Section 506J, first introduced in the CARES Act of 2020, was the legislative foundation. This 2025 guidance is its operational blueprint.
A Living List of Critical Devices
At the core of the guidance is the introduction of the 506J Device List a curated, evolving catalog of product codes for devices deemed vital in maintaining national healthcare stability. These include ventilators, IV catheters, surgical staplers, blood filtration systems, and various diagnostic platforms. The list, published and maintained on the FDA’s website, allows providers and suppliers to see which items are prioritized for early warning reporting.
As of Q2 2025, the list includes over 200 device product codes. It will continue to expand based on trends in hospital usage, market availability, clinical demand, and feedback from healthcare stakeholders.
This isn’t just another compliance hurdle, it is a proactive mechanism designed to predict and prevent downstream supply breakdowns.
Hospitals and ambulatory surgical centers can now plan further ahead, particularly for procedures relying on devices within the 506J list.
For instance, an ASC performing high volumes of laparoscopic hernia repairs can flag and stockpile essential trocars or mesh kits if a manufacturer alerts the FDA to a disruption under 506J.
The burden of notification lies squarely with manufacturers, who must assess, and report not only confirmed disruptions but potential production issues. This includes shortages of raw materials, labor disruptions, regulatory delays, or overseas manufacturing setbacks. The FDA guidance requires reports to be submitted electronically, with a streamlined process for urgent cases.
Compliance means building a transparent supply data infrastructure. Manufacturers are now encouraged to:
• Develop real-time monitoring of supply chain signals.
• Track foreign supplier performance and geopolitical risks.
• Automate alerts into internal ERP systems to trigger early 506J filings.
Distributors are in a unique position to aggregate demand and adjust stock allocation. The 506J Device List allows them to prioritize logistics for flagged items and adjust regional fulfillment protocols.
Group Purchasing Organizations (GPOs) can integrate this data into their contract portfolios. If a device under contract becomes flagged, they can provide clients with substitutes or preemptive backorders from secondary vendors mitigating short, term operational impact.
From Reactive to Predictive Supply Chain Management
This guidance represents a shift from the old model where the FDA reacted to provider complaints about supply gaps to a forward-looking, data, informed model where early warnings trigger mitigation protocols.
For instance, during the 2020–2022 IV saline shortage, it took weeks for hospitals to learn of upstream problems in Puerto Rican manufacturing plants. Under 506J, those production disruptions would be flagged within days, and the FDA could coordinate with other manufacturers to scale production or approve temporary imports.
Furthermore, the guidance enables the agency to deploy resources earlier. If a manufacturer alerts the FDA about an interruption, the agency can:
• Expedite reviews for alternative suppliers.
• Initiate emergency use authorizations.
• Temporarily modify labeling or storage requirements to expand shelf life.
Compliance Tools and Reporting Templates
The FDA has issued detailed instructions and downloadable templates for submitting 506J reports. These are accessible through the FDA’s CDRH portal and designed to integrate with most industry ERP and supply chain management systems.
Manufacturers can pre-load their product portfolios with risk indicators such as lead time buffers, supplier redundancy, and dependency flags. Doing so not only simplifies 506J compliance but also allows for stronger internal resilience planning.