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, 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draft guidance in January 2022, which is why the Agency did not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.
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. 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. 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 Act
of a permanent discontinuance in the manufacture of the device, 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. 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:
- 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.
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.
Footnotes
1. FD&C Act section 506J is codified at 21 U.S.C. § 356j.
2. FDA Guidance, "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 206J of the FD&C Act."
3. The original draft guidance was issued by FDA on January 11, 2022 and did not include drafts of current sections III.B and IV. Arnold & Porter previously issued an Advisory about the January 2022 draft guidance. In December 2022, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act), enacted as part of the Consolidated Appropriations Act of 2023, amended section 506J to address additional voluntary notifications and further required FDA to issue guidance on such voluntary additional notifications and on the list of the types of devices subject to section 506J (i.e., the 506J Device List). When FDA finalized the January 2020 draft of the guidance on November 17, 2023, at that time FDA issued section III.B (about the 506J Device List) and section IV (about voluntary additional notifications) as separate draft guidance. On January 7, 2025, FDA finalized that separate draft guidance and incorporated it into the final 506J Guidance as sections III.B. and IV.
4. FDA further states in the guidance that FDA's consideration of whether a device is critical to a PHE includes (a) whether the device is used to diagnose, treat, monitor, or prevent a serious disease or medical condition; and if the device is life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery, and (b) whether the lack of availability of the device is reasonably likely to cause serious injury or death to patients, health care workers, or others if it is not available and there are no suitable alternatives.
5. See 21 U.S.C. § 371(h)(1)(C) and 21 CFR 10.115(g)(2).
6. Section 319 of the PHS Act is codified at 42 U.S.C. § 247d.
7. Except for discontinuances as a result of an approved modification of the device.
8. Of note, the guidance does not appear to clarify whether there could be multiple manufacturers of a device for Section 506J purposes if multiple entities must list the device under section 506(j) (for example, where there is both a specification developer and a separate contract manufacturer for a device that does not require a marketing authorization).
9. Publication is subject to restrictions on release of trade secret and confidential information and subject to FDA discretion with respect to whether publication of the information would adversely affect the public health.
10. FDA, "FY25 Legislative Proposals," at p. 8.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.