Notification under 506J & Additional voluntary collections related to 506J

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 November 17, 2023.
The draft of this document was issued on January 11, 2022.
For questions about this document regarding CDRH-regulated devices, contact
[email protected]. For questions about this document regarding CBERregulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at
1-800-835-4709 or 240-402-8010, or by email at [email protected].

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 208521740. 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
[email protected] 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 240-4028010, by email, [email protected], or from the Internet at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-informationbiologics/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 ................................................................................................................. 4

D.

What Information To Include in 506J Notifications ........................................................ 8

E.

How to Notify................................................................................................................. 11

F.

Failure to Notify ............................................................................................................. 11

IV. Additional Notifications........................................................................................................ 12
V.

FDA’s Determination That a Device Is In Shortage ............................................................. 12
A.

How FDA Determines What Devices Are In Shortage.................................................. 12

B.

FDA’s Device Shortage List .......................................................................................... 13

VI. Paperwork Reduction Act of 1995 ........................................................................................ 13
Appendix A. Examples Likely to Be “In Advance of a Public Health Emergency” .................... 15

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 stakeholders in the Agency’s implementation of section
506J. This guidance serves as the baseline for information about notifications under section 506J
1

See section 506J(a).

1

(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 the 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 is concurrently
issuing the draft guidance “Select Updates for the 506J Guidance: 506J Device List and
Additional Notifications,”4 to propose revisions to Section III.B. and Section IV. of this
guidance.
Under section 506J(a), manufacturers of certain devices,5 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 in the manufacture of the device that is likely to
lead to a meaningful disruption in supply of that device in the United States” during or in
advance of a declared PHE.6 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
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-506jguidance-506j-device-list-and-additional-notifications
5
See section 506J(a) and (b).
6
See section 506J(a).

2

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.).7 In addition, under section 506J, 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.).

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.8 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
[email protected] for devices regulated by CDRH or
[email protected] 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.

7
8

See section 506J(e).
See section 506J(a).

3

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
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”:9
·

·

Devices that are critical to public health during a PHE, including those that are lifesupporting, life-sustaining,10 or intended for use in emergency medical care or during
surgery;11 or
Devices for which FDA determines information on potential meaningful supply
disruptions is needed during, or in advance of, a PHE.12

FDA is proposing a list of devices, by FDA 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 II. of the “Select Updates for the 506J Guidance: 506J Device
List and Additional Notifications” guidance. FDA intends to finalize the 506J Device List after
the comment period for that guidance closes.
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

This section will be added once the “Select Updates for the 506J Guidance: 506J Device List and
Additional Notifications” draft guidance is finalized. Until FDA finalizes the 506J Device List,
FDA intends to provide PHE-specific recommendations on devices for which a manufacturer of
such devices is required to notify FDA in accordance with section 506J, as appropriate.

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
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 7 calendar days after an interruption in
manufacturing occurs, or no later than 7 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
9

See section 506J(a) and (j)(1)(A).
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.”
11
See section 506J(a)(1).
12
See section 506J(a)(2).
10

4

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 7 calendar days after
the permanent discontinuance or meaningful interruption occurs. With sufficient notice, FDA
can work with the manufacturer and other stakeholders 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 7 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,13 it was helpful for the 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.
(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.14

13

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.
14
Section 506J(a) makes clear that manufacturers are not required to notify of permanent discontinuances that occur
“as a result of an approved modification of the device.”

5

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 high yield
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;”15
“[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
resume operations in a reasonable period of time.”16 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.”17 For devices designed to perform more than one procedure
or diagnostic or serological test, manufacturers should provide notification of any

15

See section 506J(j)(1)(B).
See section 506J(j)(1)(C).
17
See section 506J(j)(1)(D).
16

6

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 Health and Human Services (HHS) Secretary declares a PHE under
section 319 of the PHS Act, including any renewals made by the HHS 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
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

7

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. FDA is proposing more information on the types of devices for which 506J
notifications are required in Section II. of the “Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications” draft guidance.

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.18

(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.”

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.19 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

18

See section 506J(d).
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).”
19

8

·

·

The reason for the 506J notification, selecting from the following categories:20
· 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
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

20

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.

9

·
·
·

challenges, procurement issues);
Increased or projected increased demand unable to be met by the manufacturer (e.g.,
backorder,21 allocation,22 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 stakeholder 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 to
patients and healthcare delivery in the United States; and (3) inform on the need for
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

21

For purposes of this guidance, FDA interprets “backorder” to mean temporarily out of stock.
For purposes of this guidance, FDA interprets “allocation” to mean the practice of rationing customer orders at
times of supply shortage.
22

10

·

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.”23

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 website24 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
[email protected] for devices regulated by CDRH or
[email protected] 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 notification 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.25 The manufacturer must respond to
FDA’s letter not later than 30 calendar days after issuance of FDA’s letter, setting forth the basis
for noncompliance and providing the required information on the discontinuance or
interruption.26 Not later than 45 calendar days of issuance of the letter to the manufacturer, 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.27
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.28

23

See section 506J(f).
See FDA’s website on “Notify the FDA About a Medical Device Supply Chain Issue,” available at
https://www.fda.gov/medical-devices/medical-device-safety/contact-fda-about-medical-device-supply-chain-issue.
25
See section 506J(e)(1).
26
See section 506J(e)(2).
27
See section 506J(e)(3).
28
See section 506J(e)(3).
24

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IV. Additional Notifications
This section will be added once the “Select Updates for the 506J Guidance: 506J Device List and
Additional Notifications” draft guidance is finalized.

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.
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.29 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 group purchasing
organizations);
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 stakeholders (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.
29

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.

12

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 website30 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.
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).31

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).

30

See FDA’s website on “Medical Device Shortages List,” available at https://www.fda.gov/medicaldevices/medical-device-supply-chain-and-shortages/medical-device-shortages-list.
31
See section 506J(g)(3)(C).

13

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,
[email protected]
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).

14

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” and 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 being declared:
·
·

·
·

·

·

·

·

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 Centers for
Disease Control and Prevention Director 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 Paperwork
Reduction Act 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 FDAcommunicated 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.

15