On January 7, 2025, during the last few weeks of the Biden Administration, the U.S. Food and Drug Administration (FDA) issued a final guidance for medical device manufacturers on notifying the FDA of a permanent discontinuance or manufacturing interruption of a device under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Section 356j). Congress introduced Section 506J as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act to protect against potential medical device shortages during public health emergencies (PHEs). Section 506J mandates that certain medical device manufacturers must notify the FDA of any permanent discontinuance or interruption in the manufacture of devices that could lead to a meaningful disruption in supply during, or in advance of, a PHE. These notifications are intended to allow the FDA to help prevent, or mitigate, the shortage.
The FDA’s guidance clarifies which manufacturers must notify the FDA of such discontinuances or interruptions, which devices are subject to the reporting requirement, the timetable under which manufacturers must submit notifications, and the information required to be included in each notification. The guidance also provides insights into the FDA’s criteria for determining which devices are in shortage.
The COVID-19 pandemic highlighted the importance of emergency preparedness for the drug and medical device industries. As part of good governance, medical device manufacturers should consider now whether their products are subject to the FDA’s notification requirements and plan to submit such notifications in the event of future PHEs. Companies may also wish to assess the list of information the FDA requests in shortage notifications to identify and strengthen supply and distribution of their products to avoid shortages – even for devices not subject to Section 506J.
Below is a summary of the key insights from the FDA’s guidance.
Who Must Notify?
Section 506J applies to “manufacturers” of medical devices. The FDA interprets this term as the entity that holds the device marketing authorization (e.g., 510(k)), or, if a marketing submission is not required, the entity responsible for listing the medical device under section 510(j) of the FD&C Act. Manufacturers (as defined above) who rely on contract manufacturers or other entities are responsible for ensuring that the other entity submits the required information under Section 506J.
Which Discontinuance or Interruptions Must Be Reported?
The Act requires manufacturers of covered devices to submit notifications for permanent discontinuances or interruptions that are more than negligible and affect the ability of the company to fill orders or meet expected demand for the product. This includes medical devices that are critical to public health during a PHE and devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery.
The FDA has published a list of devices (506J Device List) that it has determined meet these criteria. The 506J Device List will evolve over time as the FDA reevaluates it.
Timing of Notifications
The Act requires manufacturers to submit notifications at least six months in advance of a permanent discontinuance or interruption in manufacturing and states that if this timeframe is not possible, the notification should be submitted “as soon as practicable.” The guidance specifies that the FDA considers “as soon as practicable” to mean no later than seven business days after the discontinuance or interruption occurs.
Under Section 506J (21 U.S.C. Section 356j), these notifications are required only during, or in advance of, a PHE. The Secretary of the Department of Health and Human Services (HHS) declares and tracks PHEs on the HHS website. Companies should track HHS and other federal, state, and local news sources to gauge whether a PHE is occurring, or is likely to occur soon, because this triggers the requirement to submit notifications.
Information to Include in Notifications
The Act requires notifications to include an indication of, and the reasons for, the discontinuance or interruption. The guidance provides additional detail on the information that companies should provide, including:
- The category or name of the device.
- The name of the manufacturer.
- A description of the discontinuance or interruption, including the reasons for it.
- The estimated duration of the discontinuance or interruption.
Manufacturers do not need to have all the information available before submitting a 506J notification because notifications can be updated at any time. If possible, though, manufacturers should include the following additional details:
- Submitter name, email, phone, company name.
- Marketing submission number, if applicable.
- The FDA Establishment Identifier number.
- Notification type (i.e., initial or update).
- The FDA product code for the device subject to the discontinuance or interruption.
- Unplanned manufacturing challenges (e.g., labor shortages, delays in raw material supply, temporary plant closures, packaging or sterilization concerns, or other unforeseen circumstances that prevent the manufacturer from meeting demand).
- Unplanned distribution challenges (e.g., shipping/transportation delays, export/import challenges, procurement issues).
- Increased or projected increased demand that the manufacture is, or will be, unable to meet (e.g., backorder, allocation, low fulfillment rates).
- Potential broader/connected interruptions (e.g., reliance on critical suppliers who are experiencing supply chain interruptions).
- Actions or circumstances affecting software-enabled devices that may disrupt healthcare operations (e.g., device cybersecurity vulnerabilities or exploits).
- Potential prevention or mitigation strategies, including interested party and customer communications.
- Inventory and production capacity, including potential expansion capabilities (e.g., estimated market share, historic and current production capacity, maximum production capacity).
Submission Process
Manufacturers should submit notifications electronically via the FDA's website. Alternatively, manufacturers may submit notifications via email. Email notifications for devices regulated by the Center for Devices and Radiological Health (CDRH) may be submitted to CDRHManufacturerShortage@fda.hhs.gov, or cbershortage@fda.hhs.gov for devices regulated by the Center for Biologics Evaluation and Research (CBER). Emails should include a subject line beginning with the word “Notification.”
Consequences of Failure to Notify
Failure to comply with the notification requirements may result in the FDA issuing a letter noting the failure to the manufacturer. Companies must respond to such letters within 30 days. The FDA may post its letter, and the company’s response, on its website; however, the FDA will refrain from doing so if it determines that the manufacturer had a reasonable basis for not notifying the agency as required.
We will continue to monitor the FDA’s actions and update you as the agency issues new guidance. If you have any questions, please do not hesitate to reach out.
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If you have any questions, or would like additional information, please contact one of the attorneys on our Health Care team or one of the attorneys on our FDA/Food, Drug & Device team.