FDA Finalizes Guidance on Notifying FDA of a Permanent Discontinuance or Interruption in Device Manufacturing Under Section 506J of the FD&C Act

The CARES Act, which was enacted in March of 2020 in the face of worsening drug and device shortages related to the COVID-19 pandemic, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) by, among other things, adding section 506J to the Act.¹ Section 506J requires that, when certain conditions are met, certain information must be submitted to the U.S. Food and Drug Administration (FDA or the Agency) to help FDA better mitigate and prevent medical device shortages. Section 506J also directs FDA to use that information to establish and maintain a public list of devices that FDA has determined are in shortage in the U.S., and to, as appropriate, prioritize and expedite marketing authorization applications and establishment inspections that could help mitigate or prevent a device shortage.

FDA finalized most of the guidance clarifying FDA’s interpretation and implementation of section 506J in November 2023 with the guidance document titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” (the 506J Guidance or the guidance).

On January 7, 2025, the Agency finalized the remaining two sections of the guidance,² including a key section (section III.B of the guidance) that establishes and discusses the list of device types for which manufacturers must issue notifications to FDA as required by section 506J. The other newly finalized section (section IV of the guidance) discusses the ability of medical device companies to voluntarily submit additional notifications to FDA beyond those required by section 506J. These two sections came about due to legislation enacted after FDA had already issued the initial 506J draft guidance in January 2022, which is why the Agency did not finalize them until recently.³

In this Advisory we provide an overview and discussion of important points from the final guidance as a whole, including the newly finalized sections.

Overview and Discussion of the Guidance

Entities and Devices to Which Section 506J Applies

Section 506J applies to “manufacturers” (which is a term defined by the guidance, as further discussed below) of medical devices that either (a) are critical to public health during a public health emergency (PHE), including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or (b) for which FDA determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency.

As required by the Consolidated Appropriations Act of 2023, FDA proposed, and as of January 7, 2025 has now finalized, a list (by FDA product code) of devices that meet the above criteria (the 506J Device List). The 506J Device List includes a wide range of devices, such as lancets, ventilators, infant warmers, catheters, hemodialysis devices, personal protective equipment, and syringes. Medical device companies should review the 506J Device List to confirm whether they are a “manufacturer” of any devices included in the list.

FDA will periodically evaluate the 506J Device List and may update it in the future. In particular, FDA notes in the guidance that consistent with section 506J, the Agency may add additional devices that are critical to address a specific PHE or if information on potential meaningful supply disruptions of the device is otherwise needed.⁴ FDA confirms in the 506J Guidance that FDA will follow FDA good guidance practices, which establish certain procedures that FDA must follow when issuing guidance, if and when the Agency adds devices to the 506J Device List. Medical device companies should keep in mind, however, that FDA good guidance practices allow FDA to significantly update guidance without prior notice and comment if the Agency determines that prior public participation is not feasible or appropriate.⁵ FDA exercised that authority frequently during the COVID-19 PHE.

Section 506J Notification Requirements

Section 506J requires manufacturers of devices on the 506J Device List to notify FDA, during or in advance of a PHE declared by the Secretary of the U.S. Department of Health and Human Services (HHS) under section 319 of the Public Health Service Act⁶ of a permanent discontinuance in the manufacture of the device,⁷ or an interruption of the manufacture of the device, that is likely to lead to a meaningful disruption in the supply of that device in the United States.

The guidance defines “manufacturer” for the purposes of Section 506J as the entity who holds the marketing authorization for the device (e.g., the 510(k)) or, if a marketing authorization is not required for the device, as the entity responsible for listing the device with FDA pursuant to section 506(j) of the FD&C Act.⁸ The guidance further clarifies that such manufacturers that rely on a contract manufacturer or others in the production process are responsible for ensuring their contract manufacturers, supply chain partners, and other such entities provide them with sufficient notice and information so that the manufacturer can fulfill its notification obligations under section 506J.

Timeframes Required for Section 506J Notifications

Section 506J(b)(1) requires manufacturers to submit a notification to FDA at least six months in advance of a permanent discontinuance in manufacturing of a device or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the United States, or, if that timeframe is not possible, the manufacturer must submit the notification to FDA “as soon as practicable.”

FDA clarifies in the guidance that the Agency considers “as soon as practicable” in this context to mean no later than seven calendar days after an interruption in manufacturing occurs, or no later than seven calendar days after the manufacturer decides to permanently discontinue the device, as applicable.

After the initial 506J notification to FDA of an interruption in manufacturing, FDA recommends that manufacturers provide updates to FDA every four weeks, unless otherwise indicated by FDA, even if the status remains unchanged.

What Constitutes a “Permanent Discontinuance,” “Interruption in Manufacturing,” and “Meaningful Disruption in Supply”

The guidance clarifies that, in the context of section 506J, FDA interprets a “permanent discontinuance” in manufacturing of a device to refer to when the manufacturer ceases manufacturing and distributing a product indefinitely for business or other reasons.

The guidance also states that FDA interprets “interruptions in manufacturing” of a device to include interruptions that occur as a result of a more than negligible decrease in manufacturing capability or situations for which a manufacturer’s supply cannot meet an increase in demand or projected demand. The guidance provides potential examples of such events, including a medical device recall, labor constraints, inability to procure necessary raw materials or components, and increased demand of the device due to a PHE.

Section 506J also provides that certain other events do not constitute an “interruption in manufacturing,” including “interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time, not to exceed 6 months” and “interruptions in manufacturing of components or raw materials so long as such interruptions do not result in a shortage of the device and the manufacturer expects to resume operations in a reasonable period of time.” For the purpose of this latter scenario, the guidance provides that FDA considers “in a reasonable period of time” to mean that the manufacturer is able to resume distribution of the device within one month.

As noted above, notification to FDA of a permanent discontinuance or interruption in manufacturing of a 506J Device is only required if it is likely to lead to a meaningful disruption in supply of the device in the U.S. Section 506J defines “meaningful disruption” as “a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product.” The guidance further clarifies that manufacturers should base their notifications to FDA on their own capacity, supply, and orders, and should not consider other manufacturers’ or competitors’ capacities or assumed capacities, or what the manufacturer understands about market demand for the device.

When Notification to FDA Is Required

Section 506J provides that notifications to FDA under section 506J are required “during, or in advance of” a PHE declared by HHS under section 319 of the Public Health Service Act (PHS Act).

The 506J Guidance provides that FDA interprets “during” a PHE to mean the time period beginning when the Secretary of HHS declares a PHE under section 319 of the PHS Act, including any renewals made by the Secretary of HHS in accordance with section 319(a)(2) of the PHS Act. The guidance further provides that FDA interprets “in advance of” a PHE to mean the time period before the Secretary of HHS may determine that a disease or disorder presents a PHE or that a PHE, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.

FDA further clarifies in the guidance that when FDA becomes aware of such conditions that are in advance of a PHE, the Agency intends to conduct outreach to or otherwise notify manufacturers of the situation and the applicability of section 506J, for example by sending an email communication and posting on the FDA website to make clear that manufacturers should, if their situation requires, submit notifications, as well as highlighting any specific devices or specific geographic areas where manufacturers should be particularly attuned and prepared to submit notifications if their situation requires.

Required and Requested Information in 506J Notifications

FDA states in the guidance that the section 506J notifications to FDA must contain the following information, as section 506J requires FDA to publish this information for each device in shortage:⁹

• The category or name of the device in shortage
• The name of each manufacturer of such device
• The reason for the shortage (from a list of eight specified categories)
• The estimated duration of the discontinuance or interruption

FDA further requests in the guidance that certain other information also be submitted to FDA in the 506J notification, such as the submitter name, email, phone, and company name, the applicable FDA Establishment Identifier (FEI) and FDA product code, as well as the manufacturer’s inventory and production capacity.

Consequences of a Failure to Submit a Notification When Required

Although failure to submit a required section 506J notification is not a prohibited act under the FD&C Act, and thus there are no criminal penalties for failing to comply, FDA may issue a letter to a company informing it of the failure to submit the notification, to which the company has 30 calendar days to respond. FDA then will publish the letter and any response from the company on the FDA website, unless FDA determines that the letter was issued in error or that the recipient had a reasonable basis for not submitting the notification.

Submission of Voluntary Additional Notifications Under Section 506J

Section 506J(h) clarifies that FDA may receive voluntary notifications pertaining to the permanent discontinuance or interruption in the manufacture of a device at any time, unrelated to the declaration or potential declaration of a PHE.

FDA’s 2025 Legislative Proposal requests that Congress amend section 506J to require section 506J notifications to FDA regardless of whether a PHE has been or may be declared.¹⁰

Conclusion

Compliance with Section 506J is mandatory for certain device manufacturers, and the guidance contains important interpretations and clarifications of FDA’s application of the statute’s provisions. It can also be difficult to predict when a new or pending public health emergency will require compliance with section 506J. Accordingly, it is important for medical device manufacturers to determine whether 506J requirements may apply to them, and consider having standing policies and procedures in place that can be implemented as necessary to ensure compliance. If you have any questions about the content discussed here or would like more information, please reach out to one of the authors of this Advisory or to your existing Arnold & Porter contact.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.