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FDA/CDRH Webinar

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Linda Ricci and Katie O’Callaghan

Office of Strategic Partnership and Technology Innovation (OST)

Division of All Hazards Response, Science and Strategic Partnerships (DARSS)

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration (FDA)

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 –

Immediately In Effect Guidance

May 11, 2020
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• Background: CDRH’s role in COVID-19 

public health emergency

• New immediately in effect Guidance: 

Manufacturer notifications under Section 

506J of the FD&C Act during the COVID19 public health emergency

• Q&A

Agenda
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CDRH plays a critical role during 

COVID-19 Public Health Emergency 

• COVID-19 pandemic triggered unprecedented increased 

demand for some devices, as well as significant disruptions to 

global medical device manufacturing and supply chain 

operations for some devices. 

• The FDA has taken many actions 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. 
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CDRH works collaboratively to prevent and 

mitigate medical device shortages 

• Manufacturers 

• Health care sector

• Professional societies

• Patient organizations

• International regulatory 

partners

• U.S. government

• Foreign governments

• Public health entities

• Supply chain entities

• Researchers / 

innovators
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• 506J 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

• This information will help prevent or mitigate shortages during the 

COVID-19 public health emergency. 

The CARES Act and 

Section 506J of the FD&C Act
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• This immediately in effect guidance: 

– Implements Section 506J of the Act during the COVID-19 public health 

emergency

–Assists manufacturers in providing the FDA timely, informative notifications 

about changes in the production of certain medical device products 

– Includes recommendations about who must notify the FDA, what information 

to include in the notification, and how to notify the FDA for the duration of the 

COVID-19 public health emergency

– Is immediately in effect and is intended to remain in effect only for the duration 

of the public health emergency related to COVID-19.

FDA Issues Guidance to Help 

Manufacturers Understand 506J 

Notification Obligations
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• Section 506J(a)(1)-(2) requires manufacturers of devices:

– that are critical to public health during a public health emergency, 

or

– for which the FDA determines information on potential meaningful 

supply disruptions is needed during or in advance of a public 

health emergency 

to notify the FDA of an interruption or permanent discontinuance in 

manufacturing of such devices. 

Who must notify? 
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• In determining whether this requirement applies, the FDA 

recommends medical device manufacturers evaluate the following 

circumstances – whether the device or accessories are:

–life-supporting, life-sustaining, or intended for use in 

emergency medical care;

–intended for use during surgery;

–used to diagnose, cure, treat, mitigate, or prevent COVID-19; or

–would be in higher-than-typical demand during the response to 

COVID-19 pandemic compared to a similar period of time.

Who must notify?
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Are the section 506J notification 

requirements applicable to me?

Subject to 506J Notification Requirements

• If a manufacturer makes a device described 

in section 506J(a)(1)-(2) and holds a 

marketing authorization from FDA, or is 

listed under section 510(j) of the FD&C Act, 

that device is subject to a notification to the 

FDA pursuant to section 506J. 

Not subject to 506J Notification Requirements

• Manufacturers of devices 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.
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• Device manufacturers must notify the FDA at least six months before 

the date of the discontinuance or interruption or, if that is not 

possible, as soon as is practicable.

–During the COVID-19 pandemic, the FDA considers “as soon as is practicable” 

to mean notification should be provided no later than 7 calendar days after the 

discontinuance or interruption in manufacturing occurs. 

• After the initial notification, the FDA recommends updates every two 

weeks, including the expected timeline for recovery, until the 

shortage risk has been resolved. This ensures the FDA can act on 

the most current information. 

When must the FDA be notified?
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What information to include:

• Section IV of the guidance includes an example of the 

recommended information to include.

–Reason(s) for discontinuance or interruption in manufacturing

–Identifying information 

–Additional information

• Any information provided to the FDA that is trade secret or 

confidential information will be treated as such, consistent with 5 

U.S.C. 552(b)(4), 18 U.S.C. 1905 and other applicable laws.
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• Medical device manufacturers should submit notifications of 

discontinuance, disruptions, or shortages to 

CDRHManufacturerShortage@fda.hhs.gov. Please include 

“Notification” in the subject line.

Where to send notification: 
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• Section 506J of the FD&C Act requires manufacturers of 

certain devices to notify the FDA of an interruption or 

permanent discontinuance in manufacturing of such devices.

• The FDA issued immediately in effect guidance to implement 

and clarify during the COVID-19 public health emergency.

• Manufacturer notifications contribute critical information to 

help the FDA assess, prevent, and mitigate shortages during 

the COVID-19 public health emergency. 

Summary
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• We are unable to answer questions about specific devices 

during this webinar, but we recommend that you reach out to 

CDRHManufacturerShortage@fda.hhs.gov, and we are 

happy to help you determine whether a notification is 

required. 

• Please begin the email subject line with the word "Question" 

to help expedite our response.

Q&A Note
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• Q: I manufacture a 510(k) cleared ventilator accessory. 

Am I required to notify?

• Yes, if you make a device described in section 506J(a)(1)-(2) 

that has marketing authorization from the FDA, or is listed 

under section 510(j) of the FD&C Act, that device is subject 

to a notification to the FDA pursuant to section 506J. 

Q&A
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• Q: I manufacture surgical gowns listed pursuant to 

section 510(j) of the FD&C Act. Am I required to notify?

• Yes, if you make a device described in section 506J(a)(1)-(2) 

that has marketing authorization from the FDA, or is listed 

under section 510(j) of the FD&C Act, that device is subject 

to a notification to the FDA pursuant to section 506J. 

Q&A
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• Q: I am manufacturing devices in light of a COVID-19 

immediately in effect guidance. Am I required to notify?

• Manufacturers of devices that are required to submit a premarket 

notification under section 510(k) of the FD&C Act to the FDA and 

obtain the 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 the FDA guidance on enforcement discretion 

during the COVID-19 public health emergency, are not subject to the 

notification requirements of section 506J.

Q&A
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Questions?

CDRHManufacturerShortage@fda.hhs.gov. 

Please include “Question” in the subject line

Slide Presentation, Transcript and Webinar Recording will be 

available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Post-market Activities; Subheading: General Policy

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