NWX-HHS FDA

Moderator: Irene Aihie

2-5-15/1:30 pm CT

Confirmation # 1335175

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NWX-HHS FDA

Moderator: Irene Aihie

February 5, 2015

1:30 pm CT

Coordinator: Welcome, and thanks for standing by. At this time participants are in a listenonly mode until the question and answer session of today’s call. At that time, 

you may press Star 1 to ask a question.

Also, at this time I would like to inform all parties that today’s call is being 

recorded. If you have any objections, you may disconnect at this time. I would 

now like to turn the call over to Irene Aihie. Thank you, you may begin.

Irene Aihie: Hello and welcome to today’s FDA webinar. I’m Irene Aihie, of CDRH’s 

Office of Communication and Education. Today’s webinar will focus on the 

final order that requires manufacturers of automated external defibrillators, 

AEDs, to submit premarket approval applications, PMAs, in order to market 

their products. This order applies to both the manufacturers of AEDs, as well 

as those companies that manufacture accessories to these products.

Today, Linda Ricci, from the Office of Device Evaluation here in CDRH, will 

present an overview of the final order and clarify what it means for 

manufacturers. Following Linda’s presentation, we will open the line for 
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questions. To assist Linda with the Q&A portion are other subject matter 

experts from CDRH.

Now, I give you Linda...

(Linda): Good afternoon. My name is (Linda Ricci) and I work in the office of device 

evaluation in the Center for Devices and Radiological Health.

Today’s webinar is intended to provide an overview of the final order, with a 

primary focus on what is expected as stated in the final order from 

manufacturers of these devices in terms of the timeline for submitting PMA.

Today’s webinar will cover the following items: 1. An overview of the final 

order. 2. A discussion of the timeline for submitting PMA’s for new devices 

or new accessories. 3. A discussion of the timeline for submitting PMA’s for 

AED devices that are currently distributed. 4. A discussion of the timeline for 

submitting PMA’s for AED accessories that are currently distributed. And 

lastly, what we envision as the next step for manufacturers.

The Food and Drug Administration is issuing a final order to require the filing 

of premarket approval applications, or PMA’s, for automated external 

defibrillator systems, which consist of an AED, and those AED accessories 

necessary for the AED to detect and interpret an electrocardiogram and 

deliver an electrical shock.

The final order can be found at the link provided on this slide. The order 

covers both the AED device itself and all accessories that are necessary for the 

AED to detect and interpret an electrocardiogram and deliver an electrical 

shock. Examples of these accessories include pad electrodes, batteries, 

adaptors, and hardware keys for pediatric use.
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So what does a final order mean? Basically, it means the devices or 

accessories that have not received a 510(k) clearance will need to receive a 

PMA approval prior to beginning distribution.

AED devices which have received a 510(k) clearance may continue to be 

distributed as long as the device is included in an intent to file, and subsequent 

PMA within the time frame that will be discussed in the following slides.

AED accessories that have received the 510(k) clearance may also continue to 

be distributed, as long as they are included in a PMA within the timeframe 

laid out in the order. 

Just to be clear, devices or accessories for which a 510(k) clearance was not issued, must 

receive a PMA approval before the device can be legally marketed. This 

applies to both the devices and the accessories.

The intent to file is a mechanism by which a manufacturer of a currently 

marketed AED device can indicate to the agency which devices or device the 

manufacturer intends to include in the PMA. The manufacturer can continue

to distribute devices that are included in an intent to file until the PMA is 

submitted, but no longer than 18 months. The intent to file must be formally 

submitted to the agency within 90 days, from the date of the final order 

publication -- this would be around May 4, 2015 -- and it must include a list of 

all devices, including model numbers and 510(k) numbers for which a PMA 

will be sought.

Any currently marketed device which is not included in the intent to file must 

cease to be distributed as of May 4, 2015. As a reminder, the intent to file is 

only needed for AED devices that are currently marketed. AED accessories do 

not need to have an intent to file.
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For AED devices that were identified in the intent to file, a PMA must be 

submitted within 18 months of the date of the final order, which would be 

August 3, 2016. For devices included in the PMA, distribution can continue 

while the PMA is under review. I also want to note that multiple public access 

defibrillators may be submitted in a single PMA. Likewise, multiple 

professional use devices can also be submitted in a single PMA. And 

necessary AED accessories can also be included in either device PMA.

If a notice of intent to file a PMA for a currently marketed AED device is not 

submitted within 90 days of the effective date of the final order, or a PMA is 

not approved, then the manufacturer must cease distribution of the device or 

the device will deemed to be adulterated, and subject to seizure and 

condemnation.

Moving to currently marketed AED accessories. The necessary AED 

accessory is not included in the device PMA and that accessory is currently 

marketed, the PMA must be submitted within five years of the date of the 

final order. As with the currently marketed AED devices, distribution can 

continue while the PMA is under review.

This table summarizes the timeline for submission for AED devices and 

accessories that are currently marketed. So for the intent to file, AED devices 

have 90 days in which to submit an intent to file, then the AED’s that are 

included in that intent to file can continue to be distributed for 18 months. 

AED’s that are not included in the intent to file may only be distributed for the 

next 90 days, or until May 4. For accessories, the intent to file is not 

applicable.
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The timeline for filing a PMA for AED devices that are currently on the 

market is within 18 months, and for accessories, it’s within 60 months. You 

may continue to distribute those devices that are included in a PMA until a 

not-approvable decision or a denial decision letter is issued. And of course, 

you can continue distribution if an approval order is issued.

Next up, for manufacturers, you need to file an intent to file for an existing 

devices, followed by a PMA. Important to remember that the intent to file is 

only for AED devices. For AED accessories that you intend to continue to 

market, you need to file a PMA within five years. For any new device or 

accessory that is not cleared through the 510(k) process, you need to file a 

PMA. We also strongly encourage all manufacturers to use a pre-submission 

process to obtain specific feedback from the agency. This can be with regards 

to your upcoming submissions or any questions that you have regarding your 

current devices.

For device users, we encourage you to continue to use the devices as needed 

and continue to maintain your devices per the manufacturer’s instructions.

Now I can take your questions.

Coordinator: Thank you. At this time, if you would like to ask a question, please press Star

1 on your touchtone phone. Please insure your phone is unmuted and record 

your name clearly at the prompt. Once again, that is Star 1 on your touchtone 

phone. It takes a few minutes for the questions to come through, please stand 

by.

Our first question comes from (John Pardo). Go ahead, your line is open.
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(John Pardo): Yes, hello. I was wondering, for the devices that are in distribution now, under 

what paradigm -- PMA or 510(k) -- should manufacturers adhere to when 

making modifications, both before the PMA is submitted and during review?

(Linda): Certainly. For modifications to existing devices, during this transition period, 

before a PMA has been approved, it depends on the nature of the change. If 

there is a change that’s needed due to a part obsolescence or due to a safety 

issue, the agency will work with you to make sure that that change is 

implemented appropriately. In terms of new features that are being added to a 

device, those will need to be included in a PMA prior to market distribution.

(John Pardo): Thank you.

Coordinator: Thank you. And I’m showing no further questions at this time. Just one 

moment, please, we did have a few more questions come through. The next 

question comes from (Matt Spencer). Go ahead, your line is open.

(Matt Spencer): I was wanting to know if manual defibrillators with an AED function are 

covered under this order?

(Linda): Yes, any device that has AED function is covered under this order.

(Matt Spencer): Thank you.

Coordinator: Thank you. The next question comes from (Stuart Scholman). Go ahead, your 

line is open.

(Stuart Scholman): (Matt) asked the question that I wanted to ask. Thank you.

Coordinator: Thank you. Please stand by for the next question. Comes from (Darryl 

Hughes). Go ahead, your line is open.
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(Darryl Hughes): Yes, that question’s already by answered by - or asked and answered. Thanks.

Coordinator: Thank you. One moment. The next question comes from (John Pardo). Go 

ahead, your line is open.

(John Pardo): Thank you. What additional data requirements -- if any -- will FDA impose to 

device function, which are not associated with AED functionalities, such as 

monitoring function?

(Linda): So it is the intention of the agency to look at things in the premarket, such that 

they support the intended use of the device, in much the same way as we have 

been. Certainly for the AED functions they need to have a reasonable 

assurance of safety and effectiveness, but we would not expect any change to 

the - say monitoring functions or the ECG functions that currently exist on 

some of the monitor defibrillators. We would not expect that premarket bar to 

be any different.

(John Pardo): As a follow up question, may I ask one more question?

(Linda): Sure.

(John Pardo): We interpreted - we read the rule and interpreted to include accessories 

associated with necessary AED functionality and exclude accessories not 

necessary for the AED functionality. Is that interpretation correct?

(Linda): Yes, the accessories that are not necessary for the AED functionality may very 

well be covered under a different regulation, but they are certainly not part of 

this order.
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(John Pardo): Okay, thank you.

Coordinator: Thank you. And our next question comes from (Senthiel Meckapen). Go 

ahead, your line is open.

(Senthiel Meckapen): I think my question has been answered, but I (unintelligible) prior person. I 

want to give another example like an accessory -- I (unintelligible) call it like 

a cabinet that controls the temperature of the AED, how would you - which 

audit it falls under? I’d like an example.

(Linda): So I would imagine that the smart cabinets that control the AED’s, certainly 

it’s going to depend on the functionality that is included in that smart cabinet. 

But cabinets by themselves should not be covered under the final order. 

However, I would encourage you to send in a question to the agency with 

specific functionality for any specific cabinet that might have additional 

capabilities, just to make sure we’re all on the same page.

(Senthiel Meckapen): Thank you.

Coordinator: Thank you. And I’m showing no further questions at this time.

Recording: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions.

Coordinator: Seems like we have some more questions.

Coordinator: Just one moment please, for the next question. Coming from (Beverly 

McGrane). Go ahead, your line is open.
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(Beverly McGrane): Yes, hi. This is (Bev McGrane). So I was wondering, the rule talks about 

the accessories that will not be part of PMA order. If we’re adding a new, 

non-PMA related accessory functionality of the AED, are we going to have to 

have the 510(k) approved first and then do the PMA?

(Linda): So, I mean, there is a couple questions I think within your question, so let me 

take a stab at what I believe your question to be. So if you have an accessory 

that will be covered under a separate regulation, and could be cleared as a 

510(k) under a separate regulation, would you need to get it cleared as a 

510(k) prior to its incorporation into the AED? And my answer is some of that 

depends on the business aspect of what you’re trying to do. Certainly if you 

wanted that as a separate accessory, with its own clearance, then you could 

take it through the 510(k) process. If however, you were only going to use this 

with a AED, then you would want to get that approved through the PMA for 

use with the AED.

(Beverly McGrain): Okay, so follow up question to that would be, if that’s the case, is that 

accessory going to be held to the same PMA standards as the AED, or would 

it be held to the 510(k) standard?

(Linda): So in terms of the necessary data that we would want to see with regards to 

demonstrating performance, the accessory that would otherwise be 510(k) will

be held to the 510(k) performance bar. In as much as the accessory interacts 

with the AED and may impact the hazards or mitigations associated with that 

class 3 device, we would want to see that laid out.

(Beverly McGrain): Okay, thank you.

Coordinator: Thank you. Our next question is from (Elaine Duncan). Go ahead, your line is 

open.
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(Elaine Duncan): Yes, you mentioned the pads may be included in the PMA application. So if a 

pad manufacturer wanted their device - their pad to be included in an AED 

PMA, the pad manufacturer file this information with the device master file?

And, the second part of the question is, does the pad use with the AED require 

clinical data for use with that pad?

(Linda): So, I'm going to start with the second part of the question, because I think that 

one’s a little more straightforward. The information that we would expect for 

pads with regards to demonstrating an assurance of safety and effectiveness 

generally will not require clinical data. And we did discuss that in the final 

order and in some of the questions in response to the final order - or to the 

proposed order. Generally speaking, there’s andequte animal models and 

bench testing that can be done with pads to provide the necessary performance 

data.

As to your first question, if a manufacturer - if a pad manufacturer would like 

to pursue that way of getting their pads approved in a PMA, then certainly we 

are open to that discussion, and I would recommend that you coordinate with 

a AED device manufacturer or - and talk with the FDA about the specifics 

about how that could be moved forward.

(Elaine Duncan): Thank you.

Coordinator: Thank you. Our next question is going to come from (Larry Star). Go ahead, 

your line is open.

(Larry Star): Thank you. If for whatever reason, an AED or its accessories do not receive 

PMA acceptance, is there any requirement to inform the users that this 

situation exists?
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(Linda): So certainly we would want to - the manufacturers to make aware certainly for 

devices that are currently market approved. We would be interested in making 

sure that all of the devices that were under that umbrella, that are currently 

distributed, everyone would know the status of that. As to the exact regulatory 

actions that we would take with regards to those devices, that would be 

something that we would have to look into and is a little bit beyond what I am 

prepared to discuss today. But I understand your question and it’s definitely 

something that we need to make sure that we’re aware of going forward.

(Larry Star): Okay, thanks.

Coordinator: Thank you. Our next question is from (Darryl Hughes). Go ahead, your line is 

open.

(Darryl Hughes): Thank you. To what extent does this order apply to distributers of recertified 

AED’s?

(Linda): As we discussed in the final order in the questions, and our responses to the 

questions that came as a response to the proposed order, refurbishers and 

resellers, if they meet the definition of a device manufacturer, would fall 

under this final order. So if there is a refurbisher that is taking the devices and 

changing them in some way, or fixing them and reselling them, then they 

would fall under this final order. And just to point to, I believe that was 

question 16 in the final order.

(Darryl Hughes): Now, as a follow up, I take that as long as there’s not a change to the specs 

from the original - how the AED was originally manufactured, there would 

not be a need for compliance with the PMA process by the recertified 

distributer, correct?
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(Linda): I think there is - we need to be clear about what it means to be a refurbisher 

and I would like to make sure that we’re all talking about the same thing. 

Certainly, if you change the specification, it’s very clear. If you’re not 

changing the specification, but you’re fixing the device in any way, then I 

believe we also consider that a refurbisher and you would be subject to this 

order.

(Darryl Hughes): Okay, thank you.

(Linda): And if you have any questions about whether the actions that you are doing 

with regards to the device, then I would recommend that you come in and talk 

to us and we can be more specific about your specific case.

(Darryl Hughes): Okay, thank you.

Coordinator: Thank you. And again, as a reminder, if you do have a question please press 

Star 1 on your touchtone phone. Once again, that is Star 1if you have a 

question. Our next question will come from (Kathy Roberts). Go ahead, your 

line is open.

(Kathy Roberts): I have a question about AED’s that are at user sites that are no longer being 

manufactured by the company. Will they need to be included in the PMA in 

order for us to continue selling the necessary accessories?

(Linda): They will not need to be included in the PMA for you to continue selling the 

necessary accessories for those devices. And that is one of the reasons that we 

allow the accessory manufacturers the extended five year time table for the 

PMA’s, so that the situation that you’re describing would be covered.
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(Kathy Roberts): Thank you.

Coordinator: Thank you. Our next question is from (John Pardo). Go ahead, your line is 

open.

(John Pardo): Yes, is the (unintelligible) a noble approach that was outlined recently and 

draft guidance on accessories, does that apply here?

(Linda): In terms of the accessories that were not identified in the final order, then 

certainly that draft guidance should be considered when preparing submission.

Coordinator: Thank you. And I’m showing no further questions at this time. One moment 

please. Next question is from (Greg Rubin). Go ahead, your line is open.

(Greg Rubin): With the new PMA submissions, will that drive a pre-PMA inspection for the 

manufacturer?

(Linda): Yes.

(Greg Rubin): Thank you.

Coordinator: Thank you. Our next question is from (Senthiel Neckapen). Go ahead, your 

line is open.

(Senthiel Neckepen): Yes, I have a question based on a scenario. Say if the accessories are - you 

know might be apply for the accessories and it’s been approved, and the same 

accessories could be used on a new product for example, would we then 

require another PMA to be submitted with the new product PMA?
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(Linda): So I’m going to rephrase your question, just to make sure that I completely 

understand what you’re asking. If you have an accessory that has been cleared 

through the 510(k) process, and that same accessory without changes is able 

to be used with a different product, can that 510(k) clearance still be used for 

the new product? And I’m going to go back to new accessory, and any new 

accessory would need to have a PMA approval prior to marketing. An existing 

accessory, which it sounds like what you’re talking about, would not need to 

have a PMA in house for five years.

(Senthiel Neckepen): Okay, thank you.

Coordinator: Thank you. Our next question is from (Elisabeth George). Go ahead, your line 

is open.

(Elisabeth George): Yes, just to follow up on your comment about the accessories for nonpresently selling defibrillators. You mentioned that’s why you had the 60 

month timeframe, but in some cases that device may continue to be utilized 

well beyond the five years. So is the expectation that those accessories then be 

handled as a PMA, or does it go well beyond that 60 month time frame?

(Linda): The final order allows for five years and we certainly will reconsider as we get 

closer to that timeframe about the number of devices impacted and how we 

will proceed.

(Elisabeth George): Thank you.

Coordinator: Thank you. And I’m showing no further questions at this time.

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

thoughtful questions. Today’s presentation, along with the slide presentation 
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and transcript will be available on the CDRH webinar page at 

www.fda.gov\cdrhwebinar by Friday, February 13. If you have additional 

questions about this final order, please use the contact information provided at 

the end of the slide presentation. As always, we appreciate your feedback. 

Again, thank you for participating. This concludes today’s webinar.

Coordinator: Thank you. That does conclude today’s conference. Thank you for 

participating. You may disconnect at this time.

END