Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act
Guidance for Industry and
Food and Drug Administration Staff
Document issued on January 7, 2025.
A draft select update to this document was issued on November 17, 2023.
This document supersedes “Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing of a Device Under Section 506J of the FD&C
Act,” issued on November 17, 2023.
For questions about this document regarding CDRH-regulated devices, contact
CDRHManufacturerShortage@fda.hhs.gov. For questions about this document regarding CBER-
regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at
1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
OMB Control No. 0910—0491
Current expiration date available at https://www.reginfo.gov.
See additional PRA statement in Section VI of this guidance.

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2022-D-0053. Comments may not be
acted upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document
number GUI00021003 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
WO71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
8010, by email, ocod@fda.hhs.gov, or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.

Contains Nonbinding Recommendations
Table of Contents
I. Introduction .................................................................................................................................1
II. Background .................................................................................................................................2
III. Policy for Notifying FDA of an Interruption or Permanent Discontinuance in Manufacturing 3
A. Who Must Notify ............................................................................................................. 3
B. 506J Device List ............................................................................................................... 4
C. When to Notify ................................................................................................................. 6
D. What Information To Include in 506J Notifications ...................................................... 10
E. How to Notify................................................................................................................. 13
F. Failure to Notify ............................................................................................................. 13
IV. Additional Notifications...........................................................................................................14
V. FDA’s Determination That a Device Is In Shortage .................................................................15
A. How FDA Determines What Devices Are In Shortage.................................................. 16
B. FDA’s Device Shortage List .......................................................................................... 16
VI. Paperwork Reduction Act of 1995 ...........................................................................................17
Appendix A. Examples Likely to Be “In Advance of a Public Health Emergency” .....................18

1
Notifying FDA of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.
I. Introduction
The Food and Drug Administration (FDA or Agency) is issuing this guidance to address section
506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3121 of the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. 116-136 (March
2020), as it relates to notifying FDA of a permanent discontinuance or interruption in the
manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that
device during or in advance of a public health emergency (PHE).
FDA plays a critical role in protecting the United States from threats, such as emerging
infectious diseases, and other PHEs. Section 506J requires manufacturers to notify FDA, during
or in advance of a PHE, of a permanent discontinuance in the manufacture of certain devices or
an interruption in the manufacture of certain devices that is likely to lead to a meaningful
disruption in supply of that device in the United States.1 This guidance is intended to assist
manufacturers in providing timely, informative notifications about changes in the production of
certain medical devices that will help prevent or mitigate shortages of such devices. This
guidance also recommends that manufacturers voluntarily provide additional information to
better ensure FDA has the specific information it needs to help prevent or mitigate shortages
during or in advance of a PHE.
FDA is issuing this guidance to assist interested parties in the Agency’s implementation of
section 506J. This guidance serves as the baseline for information about notifications under
1 See section 506J(a).

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section 506J (hereafter referred to as “506J notifications”) during or in advance of any PHE. If
FDA determines it is appropriate, we may issue individual, PHE-specific updates as appendices
to this guidance or individual, PHE-specific guidance documents, among other potential options.
Such decisions will be made on a case-by-case basis and will be determined by the specific
situation and informational need.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. Background
On March 27, 2020, the CARES Act was signed into law. Section 3121 of the CARES Act
amends the FD&C Act by adding section 506J to the statute. Section 506J of the FD&C Act
provides FDA with new authorities intended to help prevent or mitigate medical device
shortages2 “during, or in advance of, a public health emergency declared by the Secretary under
section 319 of the Public Health Service (PHS) Act.”3
On December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New
Threats, and Pandemics Act (PREVENT Pandemics Act) was signed into law as part of the
Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (hereafter referred to as the “FY
2023 Omnibus”). Section 2514(c) of the FY 2023 Omnibus directed FDA to issue or revise
guidance regarding requirements under section 506J and include a list of each device product
code for which a manufacturer of such device is required to notify the Secretary in accordance
with section 506J. Additionally, section 2514 of the FY 2023 Omnibus amended section 506J to
add section 506J(h), “Additional Notifications” and directed FDA to issue guidance “to facilitate
voluntary notifications.” To address these additional statutory directives, FDA has finalized
Section III.B (“506J Device List”) and Section IV (“Additional Notifications”) of this guidance
after considering public comments received during the comment period for the draft guidance
“Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.”
Under section 506J(a), manufacturers of certain devices,4 as described in more detail in Section
III of this guidance, are required to notify FDA “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” during or in
advance of a declared PHE.5 Section 506J(a) also requires manufacturers to inform FDA of “the
reasons for such discontinuance or interruption.”
2 “Shortage” is defined as “a period of time when the demand or projected demand for the device within the United
States exceeds the supply of the device.” See section 506J(j)(2).
3 See section 506J(a).
4 See section 506J(a) and (b).
5 See section 506J(a).

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If a manufacturer fails to submit the information required under section 506J(a) in accordance
with the timing set forth in section 506J(b), FDA is directed to issue a letter informing them of
such failure (see Section III.F).6 In addition, under section 506J(f), if FDA concludes that there
is, or is likely to be, a shortage of a device, the Agency will prioritize and expedite inspections
and premarket review, as appropriate, to help mitigate or prevent the shortage (see Section
III.D.3). Section 506J(g) also requires FDA to establish and maintain a publicly available, up-to-
date list of the devices that have been determined to be in shortage (see Section V.B).
III. Policy for Notifying FDA of an Interruption or
Permanent Discontinuance in Manufacturing
Under section 506J, during or in advance of a PHE, manufacturers are required to submit
notifications for devices that are critical to public health.7 Specifically, section 506J(a) of the
FD&C Act requires manufacturers to notify FDA of permanent discontinuances or interruptions
in the manufacture of a device that are likely to lead to a meaningful disruption in the supply of
that device in the United States. Notifications are not limited, under section 506J, to devices used
to diagnose, cure, treat, mitigate, or prevent a specific PHE.
This section provides additional clarification on who is required to notify FDA, when such
notifications are required pursuant to section 506J, what information FDA expects manufacturers
to include in such notifications, and how to submit notifications. If a manufacturer has questions
regarding 506J notifications, the manufacturer should contact the Agency at
CDRHManufacturerShortage@fda.hhs.gov for devices regulated by CDRH or
cbershortage@fda.hhs.gov for devices regulated by CBER, and include “Question” in the subject
line of the email. A manufacturer may still submit a 506J notification even if they have
questions.
A. Who Must Notify
For purposes of this guidance, FDA interprets the term “manufacturer” to mean 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. If a manufacturer makes a device described in section 506J(a) that has marketing
authorization from FDA, or is listed under section 510(j), that device is subject to section 506J
and the manufacturer is required to submit a 506J notification.
If a manufacturer, as defined above, relies on a contract manufacturer or others in the production
process, the manufacturer is responsible for ensuring the contract manufacturers, supply chain
partners, or other entities provide them with sufficient notice and information to fulfill their
notification obligations under section 506J.
Under section 506J, manufacturers of the following devices must submit notifications of a
permanent discontinuance or an interruption in manufacturing “that is reasonably likely to lead
6 See section 506J(e).
7 See section 506J(a).

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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”:8
· Devices that are critical to public health during a PHE, including those that are life-
supporting, life-sustaining,9 or intended for use in emergency medical care or during
surgery;10 or
· Devices for which FDA determines information on potential meaningful supply
disruptions is needed during, or in advance of, a PHE.11
FDA has developed a list of devices, by FDA product code (“product code”), for which a
manufacturer of such devices is required to notify FDA in accordance with section 506J
(hereafter referred to as the “506J Device List”) in Section III.B, below.
For purposes of this guidance, the term “device” means a device as defined in section 201(h) of
the FD&C Act that is intended for human use and that is subject to section 506J.
B. 506J Device List
Section 2514(c) of the FY 2023 Omnibus directs FDA to issue guidance on the requirements
under section 506J of the FD&C Act and to include “a list of each device product code for which
a manufacturer of such device is required to notify the Secretary in accordance with section
506J”12 (the “506J Device List”). Thus, manufacturers of a device on the 506J Device List must
notify FDA in accordance with section 506J for each such device.
FDA has developed a list of devices, by product code, according to the criteria set forth in
section 506J(a), as discussed in Section III.A. FDA solicited public comments on the draft 506J
Device List13 in addition to receiving recommendations from the General Hospital and Personal
Use Devices Panel of the Medical Devices Advisory Committee for the FDA (hereafter referred
to as the “Panel”).14 FDA subject matter experts (including product reviewers, device experts,
and clinical experts) reviewed and considered the public comments and the Panel
recommendations during the finalization of the 506J Device List.
Separately, in response to Executive Order 14001 (“EO 14001”), A Sustainable Public Health
Supply Chain, signed on January 21, 2021, FDA led an interagency effort (including FDA,
8 See section 506J(a) and (j)(1)(A).
9 21 CFR 860.3 defines a life-supporting or life-sustaining device as “a device that is essential to, or that yields
information that is essential to, the restoration or continuation of a bodily function important to the continuation of
human life.”
10 See section 506J(a)(1).
11 See section 506J(a)(2).
12 See section 2514(c) of the FY 2023 Omnibus.
13 FDA solicited comments on the draft 506J Device List according to the level 1 guidance procedures; see 21 CFR
10.115(g)(1).
14 On February 6, 2024, the Panel met to discuss and make recommendations on medical device supply chain
resiliency and shortage issues, including the proposed 506J Device List. For more information on the Panel’s
recommendations, see February 6, 2024: General Hospital and Personal Use Devices Panel of the Medical Devices
Advisory Committee Meeting Announcement.

5
Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention,
Administration for Strategic Preparedness and Response, United States Department of Veterans
Affairs) in collaboration with healthcare providers and industry representatives within the device
ecosystem, to develop a critical medical device list (CMDL). The CMDL was developed in
response to EO 14001 to provide a comprehensive list of critical medical devices necessary for
promoting public health and strengthening healthcare and the public health critical infrastructure.
The CMDL, developed by device type, is intended for use by a broad set of interested parties to
include clinicians; hospital systems; group purchasing organizations (GPOs); medical device
industry; and state, local, territorial, and tribal governments. There is some overlap between the
506J Device List and CMDL given the commonality of identifying medical devices critical to
public health. However, the CMDL is broader in scope than the 506J Device List, and the criteria
for determining devices that were included on the CMDL and 506J Device List differ.
FDA leveraged the information and perspectives shared during the collaborative efforts to
develop the CMDL, lessons learned during previous PHEs and other events that have led to
shortages of critical medical devices, and all of the information described above, including the
public comments and Panel recommendations, to develop the 506J Device List.
FDA’s website, “506J Device List,” hosts the 506J Device List. Per section 2514(c) of the
FY2023 Omnibus, manufacturers of devices that FDA has identified by product code on this
506J Device List are required to submit 506J notifications when statutory conditions are met (see
Section III.C for more information on when to notify FDA).15
FDA expects that the 506J Device List will evolve over time and FDA intends to periodically
reevaluate the list, as appropriate, according to the criteria set forth in section 506J(a). For
example, FDA may add or remove product codes during or in advance of a new PHE. Any
revisions to the 506J Device List will follow FDA’s good guidance practices16 and FDA intends
to publicize the revisions to the public through CDRH’s communication processes. If an
interested party has questions or comments regarding the 506J Device List, the interested party
should contact the Agency at DeviceShortages@fda.hhs.gov for devices regulated by CDRH or
cbershortage@fda.hhs.gov for devices regulated by CBER and include “506J Device List
Inquiry” in the subject line of the email.
(1) Devices FDA has determined are “critical to public health
during a public health emergency” under Section 506J(a)(1)
The 506J Device List contains those devices FDA has determined are “critical to public health
during a public health emergency” within the meaning of section 506J(a)(1). FDA focused on
those devices that are critical to public health during a PHE. In determining whether a device is
critical to public health during a PHE, FDA considers a number of factors. For various reasons,17
and consistent with the language of section 506J, FDA considers whether a device is critical to
public health during any PHE.18 However, FDA also considers whether there are certain devices
15 See section 506J(a).
16 See 21 CFR 10.115(g)(4).
17 For example, multiple PHEs may exist at one time.
18 Some devices, such as personal protective equipment devices, may be critical to public health during any PHE.

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that may be critical to specific PHEs.19 For example, FDA’s consideration of whether a device is
critical to a PHE includes, but is not limited to, the following:
· 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” (section 506J(a)(1)).
· Whether the lack of availability of the device is reasonably likely to cause serious injury
or death to patients, healthcare workers, or others if it is not available and there are no
suitable alternatives.20
These considerations, coupled with FDA’s experience in responding to previous supply chain
disruptions and shortages and the subsequent continued implementation of section 506J has
informed the development of the 506J Device List. The product codes set forth in this list reflect,
at this time, the product codes that FDA has determined are critical to public health during a
PHE, and for which manufacturers should notify FDA, as appropriate. However, if FDA learns
new information, consistent with the factors summarized above, FDA intends to reevaluate the
product codes that are critical to public health during a PHE and update the 506J Device List
accordingly. As previously stated, any revisions to the 506J Device List will follow FDA’s good
guidance practices.21
(2) Devices for which FDA has determined additional
information is needed under Section 506J(a)(2)
During or in advance of a PHE, FDA may also identify, under section 506J(a)(2), devices for
which we have determined “that information on potential meaningful supply disruptions” is
needed. In making such determinations, FDA’s considerations may include, but not be limited to,
devices that are specific to a type of illness or event (e.g., respiratory illness; traumatic burns
and/or wounds resulting from a disaster).
If FDA determines there are devices for which information on potential meaningful supply
disruptions is needed during a specific PHE, FDA intends to add such product codes to the 506J
Device List to assist manufacturers in determining whether they must submit a 506J notification
to FDA.
C. When to Notify
Section 506J(b)(1) requires manufacturers to submit a notification 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
19 Specific PHEs may have certain devices that are critical to that specific PHE. For example, diagnostic tests may
be critical to a specific PHE.
20 For purposes of this guidance, FDA considers a “suitable alternative” to mean an alternate FDA authorized or
legally marketed medical device, procedure, drug, or other intervention that could be used to address a medical
condition or disease. FDA considered whether there are suitable alternatives during the development of the 506J
Device List and intends to continue to factor in this consideration when updating the 506J Device List, as
appropriate.
21 See 21 CFR 10.115(g)(4).

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States. If that timeframe is not possible, section 506J(b)(2) requires that notification be done “as
soon as practicable.”
For purposes of this guidance, FDA considers “as soon as practicable” to mean that a
manufacturer should notify FDA 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. In FDA’s experience, even if it is not possible
for a manufacturer to notify the Agency before an interruption or a decision to discontinue that is
likely to lead to a meaningful disruption in supply of the device, it should generally be possible
for the manufacturer to provide notice within one or two calendar days, and in most cases it
should be possible for the manufacturer to notify the Agency no later than seven calendar days
after the permanent discontinuance or meaningful interruption occurs. With sufficient notice,
FDA can work with the manufacturer and other interested parties to potentially prevent and
mitigate shortages, reducing the impact on patients and healthcare providers.
If the circumstances giving rise to a manufacturer’s 506J notification change after notifying
FDA, the manufacturer should notify FDA of this change in status as soon as practicable,
preferably within seven calendar days. For example, if the situation that caused an interruption in
manufacturing has resolved, or the manufacturer has changed the date on which the
discontinuance will take effect, the manufacturer should notify FDA of this information.
After the initial 506J notification of an interruption in manufacturing, FDA recommends that
manufacturers provide updates every four weeks, unless otherwise indicated by FDA, even if the
status remains unchanged. FDA does not anticipate recommending manufacturers provide
updates more frequently than every four weeks; however, based on the nature of the situation,
including the expected timeline for recovery, FDA may recommend updates at less frequent
intervals (e.g., every six weeks). For example, early during the Coronavirus Disease 2019
(COVID-19) pandemic,22 it was helpful for FDA to receive updates every two weeks. However,
later in the COVID-19 pandemic, as the pace at which device shortages evolved, we
recommended manufacturers provide updates every six weeks. Updates help ensure that FDA is
acting on the most current information, therefore, reducing additional outreach and minimizing
overall burden to manufacturers. We recommend such updates be submitted until the supply
chain disruption has been resolved. If updates have not been submitted, FDA may contact
manufacturers and request that the manufacturer provide the most current information about the
situation.
FDA welcomes information from manufacturers at any time that may help us better understand
supply chain challenges and promote device availability.
22 In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. The virus has been named
“SARS-CoV-2,” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). On January
31, 2020, the Secretary of Health and Human Services (HHS) issued a declaration of a PHE related to COVID-19 in
accordance with section 319 of the PHS Act (hereinafter referred to as “section 319 PHE declaration”) and
mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national
emergency in response to COVID-19. The section 319 PHE declaration related to COVID-19 expired on May 11,
2023.

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(1) Permanent discontinuances, interruptions in manufacturing
and meaningful disruptions in supply
For purposes of this guidance, FDA interprets a “permanent discontinuance” to mean when the
manufacturer ceases manufacturing and distributing a product indefinitely for business or other
reasons.23
For purposes of this guidance, FDA interprets “interruptions in manufacturing” to include those
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.
· Manufacturers experiencing an increase in demand of a device relating to a response
during or in advance of a PHE (e.g., for the detection, treatment, or prevention of a
disease relating to a pandemic, Chemical, Biological, Radiological, Nuclear, or Explosive
(CBRNE) event, or natural disaster) should notify FDA.
· Manufacturers experiencing a decrease in manufacturing capability (e.g., as a result of a
device that is subject to a medical device recall, inability to manufacture a device because
of labor constrains, or an inability to obtain raw materials or components necessary to
manufacture a device) should also notify FDA.
For purposes of this guidance, we generally do not believe the following instances should be
considered “interruptions in manufacturing.” Manufacturers experiencing:
· An increase in demand for a device due to a temporary market response (e.g., demand for
a newer version or model) generally should not submit a notification.
· Normal variations in product demand generally should not submit a notification.
The term “meaningful disruption” is defined in section 506J(j)(1)(A) 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.” For purposes of this guidance, we interpret this to mean that a
manufacturer should base its notifications to FDA on its own capacity, supply, and orders, and
should not consider other manufacturers’ or competitors’ capacities or assumed capacities, or
what it understands about market demand for the device.
Section 506J(j)(1) also provides that the term “meaningful disruption” does not include:
· “[I]nterruptions 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.”24
· “[I]nterruptions 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
23 Section 506J(a) makes clear that manufacturers are not required to notify FDA of permanent discontinuances that
occur “as a result of an approved modification of the device.”
24 See section 506J(j)(1)(B).

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resume operations in a reasonable period of time.”25 For purposes of this guidance, FDA
interprets “resume operations in a reasonable period of time” to mean that the
manufacturer is generally able to resume pre-interruption operations and resume
distribution of the devices within one month.
· “[I]nterruptions in manufacturing that do not lead to a reduction in procedures or
diagnostic tests associated with a medical device designed to perform more than one
procedure or diagnostic test.”26 For devices designed to perform more than one procedure
or diagnostic or serological test, manufacturers should provide notification of any
interruption that could lead to reduction in any of the procedures or testing capabilities.
For example, if a device can be used for five types of procedures, and the manufacturing
interruption means only four types of procedures can be performed, the manufacturer
should notify FDA.
Manufacturers are required to notify FDA of permanent discontinuances within the timeframe
prescribed by section 506J(b) through the process explained in Section III.E of this guidance. If
any of the following situations occur, FDA requests that the manufacturer notify FDA
immediately through the process explained in Section III.E of this guidance so that we may work
together with the manufacturer to help prevent or mitigate any supply disruptions:
· If a manufacturer is considering taking an action that may lead to a meaningful disruption
in the supply of a device (e.g., holding production to investigate a quality issue).
· If a manufacturer is ordered by another government entity (e.g., a state government or
foreign government entity) to take an action that diverts supply from the originally
intended customer in a manner that may lead to a meaningful disruption.
(2) During or in advance of a public health emergency
For purposes of this guidance, FDA interprets “during . . . a public health emergency” to mean
the time period when the Secretary declares a PHE under section 319 of the PHS Act, including
any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act (42
U.S.C. 247d(a)(2)).
For purposes of this guidance, FDA interprets “in advance of a public health emergency” to
mean the time period before the Secretary 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. If certain conditions exist prior to the occurrence of an outbreak or natural
disaster that signal the potential for such event to occur and that may lead to the declaration of a
PHE, FDA considers such conditions to be “in advance of a public health emergency.” This
would be the case irrespective of whether a PHE is ultimately declared. See Appendix A for
more information on when manufacturers should expect 506J notifications to be required.
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 to alert them of the situation and the
25 See section 506J(j)(1)(C).
26 See section 506J(j)(1)(D).

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applicability of section 506J. For example, we may send an email communication and post on
our website in advance of an impending natural disaster to make clear that manufacturers should,
if their situation requires, submit notifications, as well as highlight any specific devices, or
specific geographic areas where manufacturers should be particularly attuned and prepared to
submit notifications if their situation requires.
A PHE may be identified in a specific geographical area that has the potential to impact a larger
geographical area. Due to the vulnerability of the medical device supply chain, a localized
interruption in the supply or demand of a product may have an impact on the national availability
of a product. Manufacturers experiencing an interruption during a PHE related to a localized
event that has the potential to lead to a meaningful disruption of the supply of the device in the
United States should notify the Agency under section 506J.
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 under section 319 of
the PHS Act. For more information on the types of devices for which 506J notifications are
required, see the 506J Device List in Section III.B.
D. What Information To Include in 506J Notifications
When submitting a 506J notification, it is important that manufacturers include the required
information to help enable FDA to understand the supply situation to determine any appropriate
and available mitigations. In some instances, the Agency may also request manufacturers to
provide additional information to help the Agency’s assessment of the supply issue and
appropriate, available mitigations. Information from 506J notifications is used by FDA to assess
whether a device is in, or potentially facing, a shortage at the time of notification.
Any information provided to FDA that is trade secret or confidential information will be treated
as such, consistent with section 552(b)(4) of title 5, United States Code, section 1905 of title 18,
United States Code, and other applicable laws.27
(1) Information required by section 506J
Section 506J(a) requires manufacturers of the devices identified in Section III.B of this guidance
to submit notifications of:
· “a permanent discontinuance in the manufacture of the device (except for
discontinuances as a result of an approved modification 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;” and
· “the reasons for such discontinuance or interruption.”
27 See section 506J(d).

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Section 506J(g) requires FDA to publish a list of devices determined to be in shortage. Under
section 506J(g)(2), FDA is required to include specific information on that list.28 For FDA to
carry out its requirements under section 506J(g)(2), manufacturers, in turn, must include the
following information in their 506J notifications:
· The category or name of the device that is the subject of the 506J notification;
· The name of the manufacturer submitting the 506J notification; and
· The reason for the 506J notification, selecting from the following categories:29
· Requirements related to complying with good manufacturing practices;
· Regulatory delay;
· Shortage or discontinuance of a component or part;
· Discontinuance in the manufacture of the device;
· Delay in shipping of the device;
· Delay in sterilization of the device;
· Demand increase for the device; and/or
· Facility closure.
· The estimated duration of the discontinuance or interruption of the device that is the
subject of the notification.
Manufacturers do not need to have all of the information before submitting a 506J notification;
506J notifications can be updated at any time to include additional information. Therefore, we
recommend that manufacturers not delay notifying the Agency until all information is available,
but instead recommend that they provide initial 506J notification as soon as practicable and
additional information as it becomes available. If manufacturers do not notify FDA within the
timelines specified in section 506J(b), FDA requests that manufacturers explain why such
timeline was not possible.
(2) Additional information to help inform FDA’s supply chain
analysis
The information in Section III.D.1 is the information needed to enable FDA to meet its statutory
obligations under section 506J(g) and to make determinations about potential supply chain
disruptions. However, to help FDA appropriately identify the specific device for which the 506J
notification has been submitted, FDA requests that manufacturers provide the following
information in their 506J notifications:
· Submitter name, email, phone, company name;
· Marketing submission number, if applicable;
· FDA Establishment Identifier (FEI) number;
· Notification type (i.e., initial or update); and
28 However, section 506J(g)(3)(C) contains a public health exception that allows FDA to not make information
collected under section 506J publicly available if we determine “that disclosure of such information would adversely
affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the
device to patients).”
29 If none of the categories listed reflect the manufacturer’s situation, we recommend the manufacturer provide
additional information in the 506J notification describing the reason for the 506J notification.

12
· FDA product code.
FDA also recommends that manufacturers submit additional information, as described below,
that will assist the Agency in determining the potential for, and criticality of, a supply chain
disruption. Examples of such additional information may include:
· 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 unable to be met by the manufacturer (e.g.,
backorder,30 allocation,31 low fulfillment rates);
· Potential broader/connected interruptions (e.g., reliance on critical suppliers who are
experiencing supply chain interruptions); and
· Actions or circumstances affecting software-enabled devices that may disrupt healthcare
operations (e.g., device cybersecurity vulnerabilities or exploits).
FDA also recommends that manufacturers submit information that could help the Agency better
assess the overall state of the market. Examples of such additional information may include:
· Potential prevention or mitigation strategies, including interested party and customer
communications; and
· Inventory and production capacity, including potential expansion capabilities (e.g.,
estimated market share, historic and current production capacity, maximum production
capacity).
This additional information, while not required, is helpful to FDA in a number of ways. In
particular, this information helps enable FDA to work more effectively with other agencies and
supply chain partners to prevent or mitigate any negative impact on patients or healthcare
providers.
(3) How FDA uses information from 506J notifications
FDA may on occasion request specific additional information depending on the type of PHE. In
addition, to inform possible mitigation efforts, FDA may follow up with manufacturers or
conduct targeted outreach where an interruption is cross-cutting or may have the potential to
impact patients.
FDA utilizes the data provided through 506J notifications, in combination with other internal and
external data sources, to perform impact assessments that are subsequently used to: (1) determine
if a medical device is in shortage or if a shortage is imminent; (2) determine potential impact(s)
to patients and healthcare delivery in the United States; and (3) inform on the need for
30 For purposes of this guidance, FDA interprets “backorder” to mean temporarily out of stock.
31 For purposes of this guidance, FDA interprets “allocation” to mean the practice of rationing customer orders at
times of supply shortage.

13
implementation of both regulatory and non-regulatory mitigation strategies (e.g., enforcement
discretion, expediting premarket review, conservation strategies, and Defense Production Act
priority ratings). For example, U.S. government partners (e.g., Administration for Strategic
Preparedness and Response; Department of Commerce; Department of Transportation) use FDA
impact assessments to inform and determine if and when mitigations should be implemented.
If FDA concludes that there is, or is likely to be, a shortage of a device, the Agency will, as
appropriate:
· “prioritize and expedite the review of a submission under section 513(f)(2), 515, review
of a notification under section 510(k), or 520(m) for a device that could help mitigate or
prevent such shortage; or”
· “prioritize and expedite an inspection or reinspection of an establishment that could help
mitigate or prevent such shortage.”32
When considering whether to prioritize and expedite FDA processes, as set forth in section
506J(f), FDA will consider information available to FDA, such as trade secret and confidential
commercial information, and whether FDA resources allow for prioritization. In making
prioritization determinations, FDA considers 506J notifications as well as other information
related to potential device shortages available to the Agency, such as the information FDA
reviews in making a shortage determination.
E. How to Notify
FDA’s website, “Notify the FDA About a Medical Device Supply Issue,” contains the most
current information about submitting 506J notifications to FDA as well as a way for
manufacturers to electronically submit 506J notifications. We recommend that manufacturers
utilize this electronic method to submit both initial notifications and update notifications.
Manufacturers submitting a large number of notifications may upload a spreadsheet using the
template provided by FDA. Additionally, for manufacturers that do not wish to utilize this
method, notifications may be emailed to CDRHManufacturerShortage@fda.hhs.gov for devices
regulated by CDRH or cbershortage@fda.hhs.gov for devices regulated by CBER, and include a
subject line beginning with the word "Notification."
F. Failure to Notify
If FDA determines that a manufacturer has failed to provide a notification as required by section
506J(a) and in accordance with the timelines set forth in section 506J(b), FDA is directed to
issue a letter informing the manufacturer of such failure.33 The manufacturer must respond to
FDA’s letter not later than 30 calendar days after the issuance of FDA’s letter, setting forth the
basis for noncompliance and providing the required information on the discontinuance or
interruption.34 Not later than 45 calendar days after the issuance of the letter to the manufacturer,
32 See section 506J(f).
33 See section 506J(e)(1).
34 See section 506J(e)(2).

14
FDA will make that letter and any response received available to the public on FDA’s website
with appropriate redactions to protect trade secrets or confidential commercial information.35
However, FDA will not post the letter and response if the Agency determines that the letter was
issued in error or, after review of the manufacturer’s response, that the manufacturer had a
reasonable basis for not notifying FDA as required.36
IV. Additional Notifications
Section 2514 of the FY 2023 Omnibus amended section 506J of the FD&C Act to add subsection
(h), “Additional Notifications.” Section 506J(h) clarifies for interested parties 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.
Under section 506J(h), manufacturers of devices that are “life-supporting, life-sustaining, or
intended for use in emergency medical care or during surgery, or any other device the Secretary
determines to be critical to the public health” may submit voluntary, additional notifications to
FDA “pertaining to a permanent discontinuance in the manufacture of the device (except for any
discontinuance as a result of an approved modification 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, and the reasons for such discontinuance or interruption.” FDA’s
interpretation of who should submit notifications using section 506J(h) is consistent with our
interpretation in Section III.A of this guidance.
For purposes of this guidance, FDA interprets section 506J(h) to clarify that FDA may receive
additional notifications about medical devices at any time, unrelated to the declaration or
potential declaration of a PHE. FDA has always accepted voluntary submissions of information
across many topics, including device supply chain matters. Section 506J(h) does not alter FDA’s
ability or authority to receive voluntary information on supply chain or other matters. 506J
notifications are intended to supplement existing collaboration and communication between
industry, FDA, and other interested parties, which proved to be essential to help mitigate supply
chain disruptions and shortages during the COVID-19 pandemic, for example, as well as when
other supply chain disruptions have occurred. For example, early in the COVID-19 pandemic,
prior to the enactment of section 506J, FDA solicited and received voluntarily information from
manufacturers of critical devices regarding supply chain disruptions and manufacturing capacity.
During the COVID-19 pandemic, FDA also received notifications regarding manufacturing
interruptions and permanent discontinuances of a wide range of devices, not all of which were
critical to public health. FDA further solicited – and received – voluntary information from
manufacturers that were not experiencing interruptions in manufacturing. This information is
imperative to FDA’s ability to help prevent and mitigate shortages. As such, any time a
manufacturer of a device is experiencing a permanent discontinuance or interruption in the
manufacture of a device, the manufacturer is encouraged to submit a notification to FDA. In
Section III.D.2, FDA provided examples of additional information to assist the Agency in
35 See section 506J(e)(3).
36 See section 506J(e)(3).

15
determining the potential for and criticality of a supply chain disruption. In line with the
examples in Section III.D.2, we recommend that manufacturers submit a 506J notification to
FDA if they are experiencing any of the following circumstances:
· 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 unable to be met by the manufacturer (e.g.,
backorder, allocation, low fulfillment rates);
· Potential broader/connected interruptions (e.g., reliance on critical suppliers who are
experiencing supply chain interruptions); and
· Actions or circumstances affecting software-enabled devices that may disrupt healthcare
operations (e.g., device cybersecurity vulnerabilities or exploits).
FDA utilizes this information to help inform our analysis of the demand and supply of medical
devices. Understanding the availability of such devices and whether or not they are in
distribution or on allocation helps inform the Agency’s determination of whether there is or
could be a shortage.
FDA encourages submission of these additional voluntary notifications to FDA within 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. Section III.C
provides more information about when to submit notifications to FDA. For these additional
notifications, we recommend that manufacturers provide updates to the initial 506J notification
when there is a change in status to help ensure that FDA is acting on the most current
information.
Section III.D describes what information to include in 506J notifications. 506J notifications may
include both information required by section 506J (see Section III.D.1) and additional
information to help inform FDA’s supply chain analysis (see Section III.D.2). Section III.E
provides more information about how to submit notifications. Section III.D provides more
information about how the Agency uses information from notifications, including actions FDA
may take to help mitigate or prevent a shortage resulting from a discontinuance or interruption in
the manufacture of a device for which a notification is received.
V. FDA’s Determination That a Device Is In Shortage
Section 506J(j)(2) of the FD&C Act defines “shortage” to mean “a period of time when the
demand or projected demand for the device within the United States exceeds the supply of the
device.” In determining whether a medical device is in shortage, FDA considers factors such as
the relevant information and data available to the Agency, including indications of supply
disruptions received through 506J notifications.

16
The analysis of information related to potential device shortages informs other measures FDA
uses to help address the PHE, including issuance of Emergency Use Authorizations (EUAs) for
products that play an important role in meeting demand.37 The analysis of information related to
potential device shortages also informs FDA’s consideration of additional mechanisms for
addressing device supply availability, including use of enforcement discretion, expediting
inspections or premarket reviews, and working with other federal partners.
A. How FDA Determines What Devices Are In Shortage
FDA carefully reviews each 506J notification we receive, and uses this information, along with
additional information on the supply and demand of the device, to determine whether a device is
in shortage. The other information FDA continuously reviews in making shortage determinations
includes, but is not limited to:
· Indications of supply disruptions (e.g., 506J notifications and additional manufacturer
information);
· Indications of distribution pressures (e.g., from distributors and GPOs);
· Indications of demand or projected demand, such as availability issues reported from
users (e.g., patients, healthcare providers, hospitals and healthcare facilities, and
associations representing these groups);
· International factors (e.g., export restriction); and
· Certain actions taken to prevent or mitigate shortages including, but not limited to,
actions taken by manufacturers, FDA, or other interested parties (e.g., a manufacturer
places product on allocation).
In determining whether a medical device is in shortage, FDA considers the entirety of relevant
and reliable information and data available to the Agency at the time of a decision.
B. FDA’s Device Shortage List
Section 506J(g) requires the establishment and maintenance of an up-to-date list of medical
devices that have been determined to be in shortage. FDA’s website, “Medical Device Shortages
List,” contains a list that fulfills this statutory obligation and will reflect the categories of devices
FDA has determined to be in shortage. The list is maintained and updated as information relating
to a shortage evolves. This list also identifies medical devices for which there has been
notification that manufacturing has been permanently discontinued (“a discontinuance”). In
times when 506J notifications are not required, FDA has more limited information about
potential disruptions in the domestic supply of critical devices and is more limited in our ability
to prevent and mitigate shortages. However, FDA intends to continue to maintain an up-to-date
device shortages list to provide transparency to the American public, based on the information
available to us.
37 During a PHE, certain products may only be available under an EUA, which requires, among other things, that
there be no adequate, approved, and available alternatives. See section 564(c) of the FD&C Act.

17
As outlined by section 506J(g)(2), this list includes the category or name of the device in
shortage, the name of each manufacturer, the reason for the shortage, and the estimated shortage
duration. The reason for the interruption identified on the list is determined by FDA considering
the following factors and categories:
· Requirements related to complying with good manufacturing practices (see section
506J(g)(2)(C)(i));
· Regulatory delay (see section 506J(g)(2)(C)(ii));
· Shortage or discontinuance of a component, part, or accessory of the device (see section
506J(g)(2)(C)(iii));
· Discontinuance of the manufacture of the device (see section 506J(g)(2)(C)(iv));
· Delay in shipping of the device (see section 506J(g)(2)(C)(v));
· Delay in sterilization of the device (see section 506J(g)(2)(C)(vi));
· Increase in demand for the device (see section 506J(g)(2)(C)(vii)); and/or
· Facility closure (see section 506J(g)(2)(C)(viii)).
As appropriate, FDA will work with manufacturers to ensure the accuracy and appropriateness of
information before posting publicly on its website. FDA may elect not to make information
collected under section 506J publicly available if the Agency determines that disclosure of such
information would adversely affect the public health (such as by increasing the possibility of
hoarding or other disruption of the availability of the device to patients).38
VI. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated 30 minutes. Send
comments regarding this burden estimate or suggestions for reducing this burden to:
FDA PRA Staff,
Office of Operations,
Food and Drug Administration,
PRAStaff@fda.hhs.gov
38 See section 506J(g)(3)(C).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. The OMB control
number for this information collection is 0910-0491 (To find the current expiration date, search
for this OMB control number available at https://www.reginfo.gov).

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Appendix A. Examples Likely to Be “In Advance of a Public
Health Emergency”
The list below, while not exhaustive, contains examples of circumstances likely to be considered
“in advance of a public health emergency.” This list is intended to help manufacturers of certain
devices understand when they may be required to submit 506J notifications in advance of a PHE
declaration:
· HHS activates the National Disaster Medical System or deploys the Strategic National
Stockpile without yet determining a PHE under section 319 of the PHS Act;
· HHS authorizes assistance for research, investigations, demonstration, and studies into
the causes, diagnosis, treatment, control, and prevention of a physical or mental disease
under section 301 of the PHS Act;
· HHS authorizes assistance in the prevention and suppression of communicable diseases
under section 311 of the PHS Act;
· HHS authorizes FDA to issue an EUA for a drug, biological product, or device intended
for use in an actual or potential emergency (“emergency use” under section 564 of the
FD&C Act);
· HHS accesses the Public Health Emergency Fund and/or has enabled the Director for the
Centers for Disease Control and Prevention to access the Infectious Diseases Rapid
Response Reserve Fund prior to declaring a PHE;
· HHS determines that a disease or disorder, including a novel and emerging public health
threat, is significantly likely to become a PHE for purposes of waiving the PRA under
section 319(f) of the PHS Act;
· Other federal, state, or other jurisdictions determine that there is an actual or significant
potential for a domestic emergency involving a heightened risk of attack with a
biological, chemical, radiological, or nuclear agent(s); or
· Other federal or state agencies determine that there is a military emergency, or a
significant potential for a military emergency, involving a heightened risk to United
States military forces with a biological, chemical, radiological, or nuclear agent or agents.
If any of these conditions arise, FDA intends to conduct outreach or otherwise notify
manufacturers of the situation and the applicability of section 506J of the FD&C Act. In
addition, because of the potential for a CBRNE event or widespread treatment-resistant
outbreaks (e.g., methicillin-resistant Staphylococcus aureus (MRSA) outbreak) leading to a PHE,
FDA recommends that manufacturers submit a notification with respect to an FDA-
communicated CBRNE event to enable FDA to work more effectively with manufacturers and
entities to prevent or limit any negative impact on patients or healthcare providers.