Device-Shortages-Guidance-2020

Contains Nonbinding Recommendations

Notifying CDRH of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act During
the COVID-19 Public Health
Emergency (Revised)
Guidance for Industry and
Food and Drug Administration Staff
June 2020
This document supersedes “Notifying CDRH of a Permanent Discontinuance or
Interruption in Manufacturing of a Device under Section 506J of the FD&C Act
During the COVID-19 Public Health Emergency” issued May 6, 2020.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Office of Strategic Partnerships and Technology Innovation (OST)

Contains Nonbinding Recommendations

Preface
Public Comment
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public
health emergency. This guidance is being implemented without prior public comment because
the Food and Drug Administration (FDA or Agency) has determined that prior public
participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency’s good guidance practices.
Comments may be submitted at any time for Agency consideration. Submit written comments to
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
All comments should be identified with the docket number FDA-2020-D-1138 and complete
title of the guidance in the request.

Additional Copies
Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders ,” available at
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-relatedguidance-documents-industry-fda-staff-and-other-stakeholders, and the FDA webpage titled
“Search for FDA Guidance Documents,” available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents. You may also send an e-mail request to [email protected] to receive an additional copy of the guidance. Please include the
document number 20032-R1 and complete title of the guidance in the request.

Questions
For questions about this document, contact [email protected].

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Table of Contents
I. Introduction ..................................................................................................................................... 1
II. Background...................................................................................................................................... 2
III. Policy for Notifying CDRH of an Interruption or Permanent Discontinuance in Manufacturing .. 3
A.

Who Must Notify CDRH ..................................................................................................... 3

B.

When To Notify FDA .......................................................................................................... 5

C.

What Information To Include in Notifications ..................................................................... 6

D.

How To Notify FDA ............................................................................................................ 7

IV. Example Notification....................................................................................................................... 7

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Contains Nonbinding Recommendations

Notifying CDRH of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the FD&C Act During
the COVID-19 Public Health
Emergency
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

FDA plays a critical role in protecting the United States from threats such as emerging infectious
diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to
providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 351 et seq.), as added by section 3121 of the Coronavirus Aid, Relief, and
Economic Security Act (CARES Act), as it relates to device shortages and potential device shortages
occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health
emergency. 1
Section 506J of the FD&C Act requires manufacturers to notify FDA 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. 2 This guidance
is intended to assist manufacturers in providing FDA timely, informative notifications about changes
in the production of certain medical device products that will help the Agency prevent or mitigate
1
2

This guidance applies only to devices regulated by the Center for Devices and Radiological Health (CDRH).
See section 506J(a) of the FD&C Act.

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shortages of such devices during the COVID-19 public health emergency. This guidance also
recommends that manufacturers voluntarily provide additional details to better ensure FDA has the
specific information it needs to help prevent or mitigate shortages during the COVID-19 public
health emergency.
This policy is intended to remain in effect only for the duration of the public health emergency
related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31,
2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance
with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
Given this public health emergency, and as discussed in the Notice in the Federal Register of March
25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease
2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this
guidance is being implemented without prior public comment because FDA has determined that prior
public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to
comment in accordance with the Agency’s good guidance practices.
In general, FDA’s guidance documents, including this guidance, 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 guidance means that something is
suggested or recommended, but not required.

II.

Background

There is currently an outbreak of respiratory disease caused by a novel coronavirus. 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, HHS issued a declaration of a public health emergency
related to COVID-19 and mobilized the Operating Divisions of HHS. 3 In addition, on March 13,
2020, the President declared a national emergency in response to COVID-19. 4
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 provides FDA with new
authorities intended to help prevent or mitigate medical device shortages 5 “during, or in advance of, a
public health emergency declared by the Secretary under section 319 of the PHS Act.” 6 The
provision includes requirements for manufacturers of certain devices, 7 as described in more detail in
3

Secretary of Health and Human Services Alex M. Azar, Determination that a Public Health Emergency Exists. (Jan. 31,
2020, renewed April 21, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak
(Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-nationalemergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
5
“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(i)(2) of the FD&C Act.
6
See section 506J(a) of the FD&C Act.
7
See section 506J(a) and (b) of the FD&C Act.

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section III, 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 a declared public health emergency. 8 FDA is
issuing this guidance to clarify and make recommendations regarding who must notify FDA, what
information to include in the notification, and how to notify FDA, for the duration of the COVID-19
public health emergency. 9 This update announces availability, on FDA’s website, 10 of a list of device
types that FDA recommends manufacturers consider in determining whether a notification under
section 506J of the FD&C Act is required during the COVID-19 pandemic.
During the COVID-19 pandemic, FDA has taken many actions 11 to help ensure that patients and
health care providers have timely and continued access to high-quality medical devices to respond
effectively to the COVID-19 pandemic. These actions include issuing Emergency Use
Authorizations (EUAs), as well as guidance documents to provide policies to help expand the
availability and capability for various diagnostic, therapeutic, and protective medical devices in high
demand during the COVID-19 pandemic. FDA continues to monitor the healthcare landscape and
supply chain for resulting shortages, or meaningful disruptions to U.S. supply, of certain medical
devices.

III.

Policy for Notifying CDRH of an Interruption or
Permanent Discontinuance in Manufacturing
A.

Who Must Notify CDRH

Under section 506J of the FD&C Act, manufacturers of the following devices must notify FDA of an
interruption or permanent discontinuance in manufacturing:
•
•

Devices that are critical to public health during a public health emergency, including those
that are life-supporting, life-sustaining, or intended for use in emergency medical care or
during surgery; 12 or
Devices for which FDA determines information on potential meaningful supply disruptions is
needed during a public health emergency. 13

For purposes of this guidance, FDA interprets the term “manufacturer” to mean the entity that holds
the medical device marketing submission authorization, or, if a medical device 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)(1) – (2) that has marketing
authorization from FDA, or is listed under section 510(j) of the FD&C Act, that device is subject to a
8

See section 506J(a) of the FD&C Act.
This guidance applies to reporting under section 506J of the FD&C Act during the COVID-19 public health emergency.
Implementation of section 506J of the FD&C Act is ongoing, and the Agency intends to provide more details regarding
implementation when they are available.
10
See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-device-types-helpdetermine-section-506j-notification-obligations
11
See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19coronavirus-pandemic#response
12
See section 506J(a)(1) of the FD&C Act.
13
See section 506J(a)(2) of the FD&C Act.
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notification to FDA pursuant to section 506J. For example, manufacturers of ventilators or
thermometers that have received 510(k) clearance, or of surgical gowns listed pursuant to section
510(j) of the FD&C Act are subject to the notification requirement in section 506J. Manufacturers of
devices, such as ventilators or thermometers that are required to submit a premarket notification
under section 510(k) of the FD&C Act to FDA and obtain FDA clearance prior to marketing the
devices in the United States, but have not received such clearance and are distributing the device in
light of an FDA guidance on enforcement discretion during the COVID-19 public health emergency,
are not subject to the notification requirements of section 506J. 14
Under section 506J of the FD&C Act, manufacturers of devices that are critical to public health
during a public health emergency, or for which FDA determines information on potential meaningful
supply disruptions is needed during a public health emergency, are required to notify FDA of an
interruption or permanent discontinuance in manufacturing of such devices. FDA recommends that
manufacturers evaluate the following circumstances when determining whether they are required to
notify FDA:
•
•
•

•

Whether the device (with or without accessories) is life-supporting, life-sustaining, or
intended for use in emergency medical care (examples could include ventilator and
ventilator tubing, hemodialysis equipment, automated external defibrillator);
Whether the device (with or without accessories) is intended for use during surgery
(examples could include cardiopulmonary bypass oxygenators, infusion pumps and
tubing);
Whether the device (with or without accessories and/or testing supplies) is used to
diagnose, cure, treat, mitigate or prevent COVID-19 (examples could include specific
supplies from diagnostic and serological specimen collection kits, reagents for extraction
or PCR amplification or serological testing, pulse oximeters, cardiac and other monitoring
equipment); or
Whether the device (with or without accessories) would be in higher-than-typical demand
during the response to COVID-19 pandemic compared to a similar period of time
(examples could include personal protective equipment).

FDA’s website also contains a list of device types and corresponding product codes that FDA
recommends manufacturers consider in determining whether they are required to notify FDA during
the COVID-19 pandemic. This list represents FDA’s current understanding of the circumstances
described above. This list is not exhaustive, and FDA intends to update this list as the COVID-19
pandemic evolves. If a device type is not included on this list, but you believe it requires a
notification under section 506J of the FD&C Act, or if you have questions regarding the device types
on this list, you should contact FDA at the mailbox listed in Section III.D. of this guidance and
include “List Question” in the subject line of the email.
If a manufacturer is not certain whether to notify FDA about a particular device, we recommend the
manufacturer contact the Agency at the mailbox listed in Section III.D of this guidance.

14

During the COVID-19 public health emergency, FDA has issued a number of guidances where it has stated that it does
not intend to object to modifications to FDA-cleared devices, or to the distribution and use of new devices, without prior
submission of a premarket notification pursuant to section 510(k) of the FD&C Act. See https://www.fda.gov/emergencypreparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders.

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B.

When To Notify FDA

Per section 506J(b) of the FD&C Act, manufacturers must notify FDA at least six months in advance
of a permanent discontinuance 15 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. 16 If that timeframe is not possible, notification should be done “as soon as is practicable.” 17
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 the discontinuance or interruption in
manufacturing occurs. With sufficient notice, FDA can work with the manufacturer and other
stakeholders to potentially prevent and mitigate shortages, helping prevent negative impacts to
patients and healthcare personnel.
The term “meaningful disruption” is defined in section 506J(i)(1)(A) of the FD&C Act 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 reporting 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(i)(1) of the FD&C Act 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 six months;” 18
“[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.” 19 For purposes of this guidance, FDA believes a
“reasonable period of time” would not exceed 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.” 20 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, this should be reported to FDA.

The COVID-19 pandemic triggered unprecedented increased demand for some medical devices, as
15

FDA interprets a “permanent discontinuance” to be a decision by the manufacturer to cease manufacturing and
distributing a product indefinitely for business or other reasons. All such discontinuances are required to be reported
within the timeframe prescribed by section 506J(b) of the FD&C Act.
16
See section 506J(b)(1) of the FD&C Act.
17
See section 506J(b)(2) of the FD&C Act.
18
See section 506J(i)(1)(B) of the FD&C Act.
19
See section 506J(i)(1)(C) of the FD&C Act.
20
See section 506J(i)(1)(D) of the FD&C Act.

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well as significant disruptions to global medical device manufacturing and supply chain operations.
For purposes of this guidance, FDA interprets “interruptions in manufacturing” to include those that
occur as a result of a decrease in manufacturing capability or increased demand.
After the initial notification of an interruption in manufacturing, FDA recommends that
manufacturers provide updates every two weeks on the situation, including the expected timeline for
recovery, even if the status remains unchanged. These updates are important to ensure that FDA can
act on the most current information. We recommend such updates be submitted until the shortage
risk has been resolved.
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 or transfer of ownership),
FDA requests that the manufacturer notify FDA immediately through the process explained in
Section III.D. of this guidance. In addition, if a manufacturer is ordered by another United States
government entity to take an action that diverts supply from the originally intended customer, FDA
requests that the manufacturer notify FDA through the electronic mailbox listed in Section III.D. of
this guidance.
If a manufacturer is not certain whether to notify FDA, we recommend the manufacturer contact the
Agency at the electronic mailbox listed in Section III.D of this guidance.
C.

What Information To Include in Notifications

Per section 506J(a) of the FD&C Act, 21 manufacturers of the devices identified in Section III.A. of
this guidance must notify FDA 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.”

When providing a notification pursuant to 506J, in addition to the information described in 506J(a),
the manufacturer should also provide FDA with appropriate identifying information, such as
marketing submission holder name, marketing submission number (if applicable), manufacturer
name (if manufacturer different from marketing submission holder), FDA Establishment Identifier
(FEI) number, device name, product code, and contact information. Having this information enables
FDA to appropriately identify the specific device for which the notification has been submitted.
In addition, FDA recommends that manufacturers submit other information, as outlined in Section IV
of this guidance, that enables us to work more effectively with other manufacturers and entities to
prevent or limit any negative impact on patients or healthcare providers during the COVID-19 public
health emergency.
Section IV of this guidance provides an example of information that FDA recommends be included
in a notification pursuant to section 506J of the FD&C Act and examples of reasons for the
21

See section 506J(a) of the FD&C Act.

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discontinuance or interruption, as well as the other information described above.
It is important to note that manufacturers need not have all of the information before submitting a
notification; 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 notification as soon as is practicable and additional
information as it becomes available.
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. 22
D.

How To Notify FDA

Notifications should be submitted via email to [email protected].
A single initial notification may include a list of all affected devices and must include the
information required by section 506J(a) of the FD&C Act. If an additional device is newly affected,
FDA recommends submitting a new notification as opposed to an update to a previous notification.

IV.

Example Notification

Note: This example is intended to illustrate the type of information that FDA recommends be
included in a notification pursuant to section 506J of the FD&C Act.
Section 1: Type of notification
 Initial notification
 Update to previous notification
Section 2: Identifier information
•
•
•
•
•
•
•
•

Marketing submission holder
Marketing submission number (as applicable)
Manufacturer name (if different from marketing submission holder)
FDA Establishment Identification (FEI) number(s) (where device is manufactured)
Generic device name
Product code
Device trade name
UDI number
 Yes; UDI numbers provided below
UDI number(s)
 No; model or catalog number(s) provided below

22

See section 506J(d) of the FD&C Act.

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Model or catalog number(s)
•
•

Contact name
Contact email and phone number

Section 3: Reason(s) for the discontinuance or interruption (more than one may apply)
 Requirements related to complying with good manufacturing practices
 Regulatory delay
 Order to divert devices from other U.S. government entities
 Shortage or discontinuance of a component, part or accessory of the device (including specific
supplies from diagnostic and serological specimen collection kits or reagents for extraction or
PCR amplification or serological testing)
 Discontinuance or disruption of the manufacture of the device
 Delay in shipping of the device (e.g., due to export or import challenges, or transportation
challenges)
 Delay in sterilization of the device
 Increase in demand for the device
 Facility closure
 Product is currently in shortage (i.e., demand currently exceeds supply)
 Product is expected to be in shortage (i.e., projected demand exceeds projected supply)
 Product on backorder (i.e., temporarily out of stock)
 Product on allocation (i.e., limiting the quantity distributed to customers to extend the life of
the existing supply)
 Product on export restriction
 Longer than usual delay from order to delivery
 Other reasons not listed above; description below.
Description of reason(s) for the discontinuance or interruption.
Section 4: Duration of discontinuance or interruption

Estimated timeframe (i.e., dates) and/or duration (i.e., number of days) of the discontinuance
or interruption.

In addition to the information in Sections 1-4, it would be helpful to FDA, during the COVID-19
public health emergency, to receive the following information to help enable FDA to better manage
any potential shortages or meaningful disruptions to the device supply chain.
Section 5: COVID-19 pandemic-specific inquiries
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•

Has the COVID-19 pandemic further affected your ability to manufacture or distribute your
device(s)?
 No
 Yes; issue(s) described below
 Labor shortages
 Lack of protective equipment for employees
 Shortage or delay in raw material supply
 Temporary plant closure
 Shipping/transportation challenges
 Export/import challenges
 Other

Additional details of issue(s).
•

Do you rely on any critical suppliers that might be affected by the COVID-19 pandemic?

 No
 Yes; impact and supplier(s) below.

Description of how reliance on critical suppliers affected by the COVID-19
pandemic might adversely impact your ability to manufacture device(s).
(If you are willing/able), names of your critical supplier(s).

Section 6: Additional information, including possible mitigations
•

Is this device manufactured on multiple lines?
 No
 Yes

•

Is this device manufactured in multiple facilities?
 No
 Yes

•

How much device inventory do you have?
Current device inventory.

•

Have you provided, or will you provide, public information for your stakeholders and
patients regarding this actual or potential shortage (e.g., Dear Healthcare Provider
(DHCP) Letters, supply or shortage information posted on your website)?
 No
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 Yes
•

Do you have a proposal for FDA to review to expedite availability of your device? What
else do you think FDA can do to help prevent or mitigate a supply disruption?
 No
 Yes

Proposal to expedite availability of device and/or for FDA to help prevent or
mitigate a supply disruption.
•

Do you have shortage mitigation plans in place that could be shared with FDA?
 No
 Yes; description below

Describe shortage mitigation plans or provide a copy as an attachment.

Section 7: Production Capacity & Market Share
Device descriptor

e.g.,
GenericDevice

Estimated Avg Historic
US market Production
share (%) Volume
[# / mo]
e.g., 10% e.g., 300

Avg Historic
US
distribution
[# / mo]
e.g., 250

Current Prod
Volume
[# / mo]

Current US
distribution
[# / mo]

e.g., 100

e.g., 100

Max
Production
Volume
[# / mo]
e.g., 500

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