FDA Webinar

Moderator: Irene Aihie

5-11-20/2:00 pm ET

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FDA Webinar: 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

Moderator: Irene Aihie

May 11, 2020

2:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in a 

listen-only mode until the question-and-answer session of today's conference. 

At that time you may press star 1 on your phone to ask a question. I would 

like to inform all parties that today's conference is being recorded. If you have 

any objections you may disconnect at this time. I would like now like to turn 

the conference over to Ms. Irene Aihie. Thank you. You may begin.

Irene Aihie: Thank you. Hello and welcome to today's FDA Webinar. I am Irene Aihie of 

CDRH’s Office of Communication and Education. Manufacturers of certain 

devices during a public health emergency are required to notify the FDA of an 

interruption or permanent discontinuing in the manufacturing of certain 

devices by Section 506J of the FDAC Act. On May 6, 2020 the FDA issued 

the guidance notifying CDRH of permanent discontinuing or interruption in 

manufacturing of device under Section 506J of the FDAC Act during the 

COVID-19 public health emergency. 

Today Katie O’Callaghan, Deputy Director of the Division of All Hazards 

Response, Science and Strategic Partnerships in the Office of Strategic 
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Moderator: Irene Aihie

5-11-20/2:00 pm ET

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Partnerships and Technology Innovation here at CDRH will present an 

overview of the guidance documents. She's joined by other members of 

CDRH.

Following the presentation we will open up the line for your questions related 

to information provided through the presentation. Now I give you Katie.

Katie O’Callaghan: Thank you Irene and thank you everyone for joining us today. Next slide 

please, Irene. So in today's webinar we will provide a few minutes of 

background on CDRH's role in the COVID-19 public health emergency and 

then get an overview of the guidance that Irene spoke to, as well as some time 

for questions and answers. Next slide please.

So as is the case with many of your organizations, CDRH within FDA has 

been working very hard to do what we can during the COVID-19 public 

health emergency for medical devices. The COVID-19 pandemic triggered an 

unprecedented increased demand of certain devices along with significant 

disruption to the global medical device manufacturing and supply chain 

operations. 

We have taken many actions to help ensure that patients and healthcare 

providers continue to have timely access to high quality medical devices that 

are needed, particularly to effectively respond to the COVID-19 pandemic.

This includes emergency use authorizations or EUAs, as well as other 

immediately in effect guidance, to help expand the ability and capability of a 

large number of diagnostic and serology tests, PPE, ventilators and other 

devices used in the treatment of COVID-19.

This also includes communication to healthcare providers on conservation 

strategies, as well as frequently asked questions and other communication 
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resources for the broader public regarding medical devices that are used 

during this public health emergency. Taken together, these actions provide 

what we consider to be the maximum appropriate regulatory flexibility to help 

healthcare providers, industry and the public. Next slide please.

In addition to these regulatory and communication actions, what may not be 

widely known to all of our stakeholders is the collaborative work that we do in 

partnership with you as well as other members of our stakeholder community 

to identify, assess, prevent and mitigate medical device shortages and their 

negative impacts on patients or healthcare providers for the healthcare sector. 

So, in doing this work we really rely on partnership from manufacturers, the 

healthcare sector, professional societies, international regulatory partners and 

a network of partners across U.S. government and foreign governments, 

public health entities, supply chain entities and of course researchers and 

innovators. Next slide please.

On March 27, 2020 the Coronavirus Aid Relief and Economic Security Act,

also known as the CARES Act, was signed into law and this added Section 

506J to the FD&C Act which relates to current and potential medical device 

shortages during the COVID-19 public health emergency. This new section, 

Section 506J, requires manufacturers to notify FDA of a permanent 

discontinuance or interruption in the manufacturing of certain devices, 

particularly those that are likely to lead to a meaningful disruption of supply 

of that device in the United States. 

This information is really critical to the work that I mentioned earlier that 

FDA does in collaboration with manufacturers and others to prevent and 

mitigate shortages, particularly during the COVID-19 public health 

emergency. These notifications are required “during, or in advance of, a 

public health emergency declared by the Secretary under Section 319 of the 
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Public Health Service Act. Next slide.

So as Irene mentioned, we issued guidance last week to implement Section 

506J of the act during the COVID-19 public health emergency. This guidance 

is also intended to assist manufacturers in providing FDA timely and 

informative notifications about such changes. It also includes 

recommendations about who must notify FDA, what information to include 

and how to notify us. And this guidance is immediately in effect and is 

intended to remain in effect only for the duration of the public health 

emergency related to COVID-19. Next slide please.

So, who must notify FDA? Section 506J(a)(1) and (2) require manufacturers 

of devices that are critical to public health during the public health emergency,

or for which the FDA determines information on potentially meaningful 

supply disruption is needed during the public health emergency, must notify 

the FDA of an interruption or permanent discontinuance in manufacturing of 

such devices. Next slide please.

To implement that, the guidance outlines some recommendations for medical 

device manufacturers to evaluate whether or not this requirement applies to 

you. We outlined the following circumstances: Whether the device or 

accessories are life-supporting, life-sustaining or intended for use in 

emergency medical care, or intended for use during surgery, or used to 

diagnose, cure, treat, mitigate or prevent COVID-19, or would be in higherthan-typical demand during the response to the COVID-19 pandemic 

compared to a similar period of time. Next slide please.

There are some nuances which are expanded upon in the guidance. Does the 

Section 506J notification requirement apply to me? Those that are subject to 

506J notification requirements include manufacturers who make a device that 
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is described in Section 506J(a)(1) and (2), and who hold a marketing 

authorization from FDA or are listed under Section 510(j) of the Act. Those 

devices would be subject to the notification requirement. Manufacturers of 

devices where the device would be one that would require a pre-market 

notification or prior marketing authorization from the FDA but do not have 

such clearance and are distributing the device exclusively in light of a FDA 

guidance on enforcement discretion during the COVID-19 public health 

emergency are not subject to the notification requirements of Section 506J. 

Next slide.

When must the notification be sent to FDA? Device manufacturers must 

notify FDA at least six months before the date of the discontinuance or 

interruption. Or if that's not possible as soon as is practicable and we interpret 

that – during the COVID-19 pandemic – as soon as is practicable to mean no 

later than seven calendar days after the discontinuance or interruption 

occurred. And after the initial notification we recommend updates every two 

weeks, including expected timeline for recovery, until the shortage risk has 

been resolved. And this is important so that we can continue to act on the most 

current information. Next slide please.

Next slide please. There we go. So what information to include? I would refer 

you to Section IV of the guidance which does include an example of 

recommended information to include. We hope this is helpful as 

manufacturers are putting together their information in their notifications. This 

includes the reason for discontinuance or interruption in manufacturing, some 

identifying information such as manufacturer name and device name, et 

cetera, as well as some additional information such as queries that are specific 

to COVID-19, additional information that could be provided on potential 

mitigations to any shortages, including how a FDA can help, how we could 

help address and alleviate shortages or other availability concerns. 
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As I mentioned earlier in the presentation, a lot of the work that we do in 

addition to regulatory action includes what we can do in partnership or 

collaboration with other entities. So this information, when provided, is very 

helpful for us to be able to use our full toolbox to prevent or mitigate 

shortages. It also requests production and distribution numbers which can also 

be very helpful to us. And any information that is provided which is trade 

secret or confidential will be treated as such, consistent with all of our usual 

laws. Next slide please.

And please send your notifications to the email box listed here, 

CDRHManufacturerShortage@fda.hhs.gov. And for notification please 

include the word “notification” in the subject line to expedite our response. 

Next slide please.

So in summary, the new section 506J of the Act requires manufacturers of 

certain devices to notify the FDA of an interruption or a permanent 

discontinuance in manufacturing of those devices. This immediately in effect 

guidance implements this section and clarifies to manufacturers what to do 

during the COVID-19 public health emergency. This information is truly 

critical to help us assess, prevent and mitigate shortages during this public 

health emergency. And with that I will conclude the overview and thank you 

for your attention. I believe we will switch gears now to questions.

Coordinator: Thank you. We will now begin the question and answer session. If you would 

like to ask a question please press star 1, unmute your phone and record your 

name clearly. Your name is required to introduce your question. If you need to 

withdraw your question, press star 2. Again to ask a question please press star 

1. And we'll take a few moments for questions to come through. Please stand 

by.
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Our first question...

(Jessica Ritsick): So before we get into the Q&A portion we did just want to note that we 

cannot answer questions during this webinar about specific devices. So if you 

do have a question about your specific device, up on the screen is our mailbox 

address which I'm sure you'll all become very familiar with. Please use that 

mailbox and mark your subject line as question at the beginning and that will 

help us get back to you as quickly as possible. Thank you.

Coordinator: Thank you. Our first question will come from (Jeffrey Brazon). Your line is 

open.

(Jeffrey Brazon): Hello. Can you hear me okay? Okay my first question is - okay great. My first 

question is in terms of the supply chain entity piece. Can you describe who are 

the entities you work with and what that might look like in practice in terms of 

a partnership with them?

(Linda Ricci): Sure. This is (Linda Ricci). The supply chain entities we work with include 

not only our own Med Sun hospitals that we can have discussions with but 

also group purchasing organizations, other of our several partners such as 

entities at HHS including ASPR, as well as specific hospitals that we might 

have other contacts with or our network of experts, just a lot of different 

people that are involved not only in the manufacture or the transportation or 

the purchasing of devices but also in the use of the device.

(Jeffrey Brazon): Okay. And then second question if that's okay, do you work with supply chain 

entities related to components in raw materials by any chance?

(Linda Ricci): We have established relationships with other entities within the supply chain.
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(Jeffrey Brazon): Okay, great. Thanks so much.

Coordinator: Thank you. Our next question will come from (Unintelligible). Your line is 

open.

Woman: Hello, thank you. So I had a question regarding meaningful disruption and 

reasonable period of time. I wonder if you might consider elaborate as to -

what exactly is meaningful? What is reasonable period of time?

Katie O’Callaghan: I believe in the guidance we identify, for the duration of the COVID-19 

public health emergency, a reasonable period of time to be one month.

Woman: Thank you.

Coordinator: Thank you. Our next question will come from (David Chadwick). You may go 

ahead.

(David Chadwick): Yes. Good afternoon and thank you for that nice presentation. I have two 

questions. The first one is if we reply to the website for shortages is that the 

same impact on the agency as going through the document now center or is 

this a different mechanism and just the data, the submission will be put in?

(Linda Ricci): Hello this is (Linda) again. So hopefully my audio is a little better now. This 

is a different type of submission for the notification and we are requesting that 

you send it through the mailbox that is highlighted on the screen right now. 

Other medical device submissions certainly go through the DCC, the 

document control center when you have obviously other types of information 

that you're sending into the agency for review or for information and 

purposes. 
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For the purpose of shortage notification we really would like for you to send 

the information into this mailbox that's highlighted on the screen.

(David Chadwick): Okay thanks (Linda). My other question deals with 506J of the CARES 

Act. And I thought - and I didn't really hear it emphasized within this webinar 

that there has to be a declared public emergency which we currently have, and 

that there are specific devices that FDA would be detailing as presumed in 

some notification beyond what the suggestions are in the CARES Act related 

specifically to COVID and just from my own information. I kind of thought 

the ebola publication was still open. So is this COVID-19 specific or is it 

farther reaching?

Katie O’Callaghan: So this guidance is specific to the COVID-19 public health emergency and 

it implements 506J for the duration of the COVID-19 public health 

emergency. As far as your question or comment about the specific devices 

because of the unprecedented scope of the impact of the COVID-19 pandemic 

rather than enumerate specific devices we laid out those four circumstances 

which I provided an overview, and you can find in Section III of the guidance, 

Section III.A. Any device that would meet any of those four circumstances are 

ones for which manufacturers should submit notification to FDA.

(David Chadwick): Thank you.

Katie O’Callaghan: Thank you.

Coordinator: Our next question will come from (Jessica Smith). You may go ahead.

(Jessica Smith): Thank you. I had a couple quick questions. One was with regard to back 
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orders. I understand that if you look at the reasons for the discontinuation or 

interruption in Section III of the guidance it includes back order as one of the 

possible reasons for that. The question is at what point is it left up to the 

manufacturer to determine when a back order is actually creating an issue in 

the marketplace because obviously with an increased demand, back orders 

could get worse. It may be two weeks. It may be six months. it doesn’t seem 

to have very clear guidance for how far back, for example, a back order might 

actually qualify for an actual shortage or interruption?

Katie O’Callaghan: Yes thank you for the question. The guidance does - I'll just clarify a 

couple of points from the guidance. One is that the reasonable period of time 

for a meaningful disruption that would qualify for notification as one month. 

And the other point of clarification is that although we are aware that 

manufacturers might have some additional information that you use for 

business decisions in terms of what else is happening in the market, because 

everything is so dynamic at the moment in particular, manufacturers should 

really make their assessment based on their own capacities rather than looking 

to make projections or estimations of the overall market impacts. So hopefully 

that clarifies.

(Jessica Smith): Yes. It sounds like there's a little bit of - it leaves room for the manufacturer to 

actually make that decision based on whatever justification they need to use to 

determine whether or not it's actually an actual, something that's reportable is 

what I'm hearing. Is that consistent with what you just stated?

Katie O’Callaghan: So manufacturers will make an assessment and the guidance includes

recommendations for things to consider in doing that. It sounds like you may 

have a more specific question about your particular circumstance, we can 

certainly take that offline if you want to contact us at that mailbox and include 

question in your subject line, we can do that quickly. Thank you.
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(Jessica Smith): Okay, yes.

Coordinator: Thank you. Our next question will come from (Elizabeth George). Your line is 

open.

(Elizabeth George): Hello (Linda) and Katie. Thank you for this update today. I did have a 

question that kind of went off of what was asked earlier about the 506J with 

clearing the emergency in a specific product. The question I have is that if a 

manufacturer makes say, three different models of a particular device that falls 

into that category and say, one of those devices has a significant shortage 

either because of back orders or a product or because it seems to have a higher 

need,but the other two versions of the product, maybe a model version could 

be as an alternative. Is the expectation that the manufacturer would then report 

even though they have alternative options that might be suffice to fulfill the 

need? And I think almost any of the different products, there could be whether 

it be an ultrasound product or defib or something like that that falls into 

meeting the definition as defined in your process, but we may have multiple 

versions of that model, of that product.

Katie O’Callaghan: Yes, thanks (Elizabeth). Great question. The answer is yes, you would still 

notify us and the reason for that is particularly with some of the examples you 

raised where this is – potentially we're talking about capital equipment in the 

hospital – although there may be alternatives there may still be a short to midterm impact on healthcare facilities for example. And so in that notification it 

would be wonderful if you could connect those dots and say we have these 

other models where we are not experiencing a shortage and that would be 

really helpful for us as we put the picture together in terms of what the 

mitigation might be or where we would need to direct our focus.
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(Elizabeth George): And that would also apply then for any accessories or supplies that might 

be utilized to support those devices as well.

Katie O’Callaghan: Yes, particularly with proprietary accessories that are used for specific 

models.

(Elizabeth George): Okay thank you. I did have one additional question and I know we asked it 

before, is that I know that there was a comment again regarding back orders 

and all of that and increased production rates and things like that. I know a lot 

of people still are wrestling with what constitutes the shortage and when do 

they feel that it would justify coming to you guys to notify. And I know you 

gave us last week a bit of an answer on that and I thought it might be valuable 

to have it shared again today.

Katie O’Callaghan: Sure, thank you. As is outlined in the guidance and for the duration of 

COVID-19 public health emergency we're talking about shortage as any time 

during which demand exceeds supply. So that could be as a result of supply 

side disruption or increased demand or a combination of both. I think what we 

have tried to help manufacturers think through with the guidance – in 

particular Section IV which is an example of the kinds of information that you 

could include – is what are some of the underlying reasons or indicators of 

discontinuance or interruption. And some indicators are ones that have been 

mentioned like the product is on back order. If demand currently exceeds 

supply or projected demand exceeds projected supply based on your historical 

ordering and production numbers, those would be indicators. If the product is 

on allocation or there are other supply side disruptions – any of those that 

could contribute to a meaningful disruption - we would recommend that you 

consider those as triggers for notifying FDA.
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Coordinator: Thank you. Our next question...

Linda Ricci: Just to add a one more quick thing to that, we would expect that you would 

provide that notification within seven days as indicated in the guidance. It 

says as soon as practicable which for this circumstance we are saying that’s 

seven days.

Coordinator: Thank you. Our next question will come from (Michael Patrini). Your line is 

open.

(Michael Patrini): So (Linda), Katie, of course thanks again. This might be a follow up question 

with kind of theme but maybe a slightly different focus. Of course 

unprecedented demand for some devices for a few months now. I'm 

wondering how it covers disruptions moving forward and shortfalls with high 

demand that currently exist. Does FDA intend for the guidance to be now and 

forward or what about situations where demand has been induced prior to

issuance of the guidance?

(Linda Ricci): So we would want companies to consider the shortfall that they are having 

perhaps in their supply throughout the COVID experience. Obviously the 

guidance is new - and the legislation is about a month old. So moving forward 

we would want you to be thinking about what is still causing supply 

disruption and provide us the information on that, do the notification for that, 

understanding that this is only for COVID. The guidance document is only in 

response to COVID using the criteria that is outlined that Katie went through.

So for example we know that there's an incredible demand for pick your 

favorite medical device and there has been incredible demand and there still 

are back orders. We would want the manufacturer of those devices to provide 

the notification as indicated in this guidance.
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(Michael Patrini): Okay thank you. That helps clarify. I appreciate it.

Coordinator: Thank you. And once again if you would like to ask a question at this time 

you can press star 1 on your phone and record your name when prompted. Our 

next question will come from (Harbanar). You may go ahead.

(Harbanar): Yes. Thank you for your time today. I have one question regarding timing on 

a response once we submit a question or a notification to the mailbox. What is 

the time frame for response through the FDA?

Linda Ricci: For a notification we will certainly let you know that we've received the 

notification and if there are any follow up questions that we have we'll get to 

those quickly. As for a particular time frame we currently don't have that and 

that may evolve depending on what the rest of the situation looks like with 

regards to that product type. As to questions we certainly want to get back to 

people as soon as possible understanding that the guidance published last 

Wednesday so that seven day mark is coming up. And if people have 

questions then we know we need to get them responses so that they can 

adequately notify us if they are obligated to do so.

(Harbanar): Thank you very much.

Coordinator: Our next question will come from (Mary Edwards). Your line is open.

(Mary Edwards): Thanks very much. I want to echo the thanks for this very clear presentation. 

Just one point I wanted to get a little bit of clarification, is - of the four criteria 

for who must notify it says life supporting or life sustaining or intended for 

use in emergency medical care or during surgery. That's a very broad range of 

devices. Is that devices being used during COVID-19 or any of the above?
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Katie O’Callaghan: Any of the above.

(Mary Edwards): Okay great.

(Jessica Ritsick): And that language is in the statute at 506J.

(Mary Edwards): Right. It's just a very broad category so thank you for offering to give some 

clarification (unintelligible) to consider that would be a device (unintelligible) 

on for clarification on this, correct?

Katie O’Callaghan: Hello Mary, this is Katie. I think it may be worth taking this offline and 

then we can get into more of the specifics. But in general our interpretation of 

that language in the statute is that those types of devices, whether or not they 

are used for COVID-19, if COVID-19 impacts in the U.S. and globally are 

affecting the availability of those, then that would disrupt critical emergency 

or surgical medical care and that's something we also want to prevent and 

mitigate when possible.

(Mary Edwards): Great, that's a clear explanation. Thank you very much. And just one last 

question on that since a lot of us occasionally have devices we're working 

through some quality problems. And FDA has already been notified of those 

would you also want to be notified because that would be a disruption until 

the quality issue has been taken care of.

Katie O’Callaghan: Yes. And certainly the right and left hands will be communicating on this 

but we do still need that notification to fulfill 506J. I think once we get into 

full implementation we can connect some of those dots. But there is a section 

in the guidance in the example notification which includes as potential reasons 
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“requirements related to complying with the manufacturing practices” or 

“other regulatory delay” related issues. So you could use those to indicate that, 

and you don’t need to reprovide any of the detailed information on those 

issues. We would be able to get that internally.

(Mary Edwards): So it’s connecting the dots for you, that makes perfect sense. Thank you so 

much.

Coordinator: Thank you. Our next question comes from (Diane). Your line is open.

(Diane): Hello guys. Thanks for the time to take these questions. Just one point, it's 

clear that the notification is specific to devices that are cleared or approved by 

FDA. But just to confirm does the notification also cover devices or products 

that are introduced under emergency authorization?

(Jessica Ritsick): So you should refer to your specific EUA and the conditions of authorization 

of your EUA. And if you have questions about the EUA as it relates you can 

email the box.

(Diane): Okay thank you. So this would be in particular to NIOSH-approved 

respirators that aren't cleared as medical devices.

(Jessica Ritsick): Again we can't answer questions about specific devices on this webinar but 

we would encourage you to look at the conditions of authorizations of your 

EUA and if you have further questions, send us an email and we can help you 

figure it out.

(Diane): Okay thank you.

Coordinator: Thank you. Our next question will come from (Elizabeth George). Your line is 
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open.

(Elizabeth George): Sorry. I had to cancel that.

Coordinator: Thank you, the question will be withdrawn. We are showing no further 

questions at this time. I will now turn the call back over to Irene Aihie.

Irene Aihie: Thank you. This is Irene here and we appreciate your participation and 

thoughtful questions. Today's presentation and transcript will be made 

available on the CDRH and our webpage at www.fda.gov/training/cdrhtolearn 

by Tuesday, May 19. If you have additional questions about today's 

presentation please use the contact information provided at the end of the slide 

presentation.

As always we appreciate your feedback. Following the completion of today's 

webinar please complete a short 13 question survey about your FDA CDRH 

webinar experience. The survey can be found at www.fda.gov/cdrhwebinar 

immediately following the conclusion of today's live webinar. Again thank 

you for participating and this concludes today's webinar.

Coordinator: Thank you. This does conclude today's conference. Thank you again for your 

participation. You may disconnect at this time.

END