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US FDA Rules for Notification of Discontinuation or Meaningful Interruption in Manufacturing

The U.S. Food and Drug Administration has finalized guidance requiring manufacturers to notify it of discontinuations or meaningful interruptions in manufacturing for many devices during, or in advance of, a public health emergency.

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January 23, 2025

By Sarah Fitzgerald, Linda Chatwin, Amelia Boldrick and Elizabeth Pugh

This month, the U.S. Food and Drug Administration (FDA), finalized guidance requiring manufacturers to notify them of discontinuations or meaningful interruptions in manufacturing for many devices during or in advance of a public health emergency (PHE).

This relatively new authority was established through the 2020 CARES Act and amended by the 2023 Omnibus Consolidated Appropriations Act, altering 21 US Code 356J. This is intended to help prevent or mitigate potential shortages by allowing the FDA to have the appropriate knowledge to consider prioritizing and expediting inspections and premarket reviews to help mitigate shortages.

Finalized guidance now available

The FDA has now finalized guidance on how they intend to interpret and enforce requirements for notifications for manufacturers.

The final guidance Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act interprets which devices are considered applicable, what information that is required, timelines for providing this information and other expectations.

US 506J notification requirements

Manufacturers of devices that could be important during a PHE must notify the FDA of a meaningful interruption or discontinuance for such medical devices. The list of devices by product codes determined to be critical to public health during a PHE is extensive and is expected to be updated by FDA periodically. The products range from common, multi-purpose devices (like lancets and surgical gowns) to in vitro diagnostics (such as metabolic panel tests) to devices intended to treat acute conditions (such as mechanical ventilators).

Per Section 506J, these notifications would only be required during or before a PHE. Per the FDA guidance document, Section III.C.2.:

“Under section 506J, manufacturers are required to submit notifications for devices that are critical to public health, irrespective of whether the devices are related to a specific PHE for which FDA has indicated to be “in advance of,” or that has been declared…”

And per Section III.B.

“The 506J Device List contains those devices FDA has determined are “critical to public health during a public health emergency”…”

Therefore, and as further described throughout the guidance, the 506J Device List is the list of devices that the FDA considers that manufacturers are required to provide notification whenever a PHE is announced or the FDA notifies of a potential PHE (“in advance of”), as they consider these devices to be critical prior to any potential PHE. They may also declare additional devices in advance of or during any specific PHE. If the FDA becomes aware of such conditions that are in advance of a specific PHE, the Agency plans to alert manufacturers of the situation and the applicability of section 506J for additional device types (product codes).

The manufacturer is required to submit a notification at least six months prior to a planned permanent discontinuation or interruption in manufacturing of a relevant device that is likely to lead to a meaningful disruption in supply of the device in the U.S. If that timeframe is not possible, the notification should be done no later than seven calendar days after an interruption in manufacturing or after the manufacturer chooses to permanently discontinue the device. The FDA provides a webform for these notifications and, alternatively, allows them to be submitted by email. Status updates are recommended every four weeks and when a significant change has occurred for a meaningful interruption.

It is important to note that the FDA has provided some context to what they consider a meaningful interruption. In general, an interruption that is anticipated to last less than one month is not considered meaningful (See Section III.C.1), but the guidance should be consulted for additional information. It should also be noted that per Section V.5., an increase in demand for the device may also be considered as leading to a meaningful interruption if the manufacturer cannot keep up with the demand in being able to provide the device.

Additionally, the FDA encourages manufacturers to voluntarily submit 506J notifications for any device at any time that a permanent discontinuation or interruption in manufacturing could impact the standard of care in the US, whether or not the device is on the 506J list.

Overview and comparison to European Regulation Art 10a

As we at Emergo by UL reported in November, the Medical Devices Coordination Group (MDCG) published a Q&A Guidance covering Europe’s similar requirement (MDR/IVDR Art. 10a). The European requirement for reporting interruption or discontinuation in supply of certain medical devices applies as of January 10, 2025.

There are major differences between the two markets

While the US has a list of products for which the notification would be required, the EU requirement is not specific to a prescribed list but would be applicable for all devices, with the exception of custom-made devices, and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health in a Member State. The EU system places the burden of determining whether their product would require a notification on the manufacturer while the U.S. system requires all products under the prescribed list of product codes, both the list of product codes expected to apply to any PHE and any specific list(s) that the FDA may create, to be included.

To whom the manufacturer must notify also differs. In the U.S., only the FDA needs to receive the 506J notification. Under Art. 10a of the European Regulation, the manufacturer is required to notify the economic operators (includes the authorized representative, importer, distributor and if applicable a system and procedure pack producer), health institutions and healthcare providers in addition to the competent authority of the Member State where the manufacturer or their authorized representative is located.

Concluding remarks

Two large medical device markets have ushered in new requirements for the notification of interruptions and discontinuations in the supply of medical devices. In both cases, these are additional requirements broadly applicable to a wide range of medical devices and manufacturers, but details are significantly different. It is critical that manufacturers are aware of these new requirements to remain compliant with regional expectations. We at Emergo by UL will continue to monitor for potential further clarification and action from the FDA.

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