FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 1

FDA Webinar Series - Enforcement Policy for Sterilizers, Disinfectant Devices, 

and Air Purifiers During the Coronavirus Disease 2019

(COVID-19) Public Health Emergency

Moderator: Irene Aihie

December 8, 2020

12:00 pm ET

Coordinator: Good afternoon and thank you for standing by. I'd like to inform all 

participants that your lines have been placed on a listen-only mode until the 

question-an- answer session of today's call. Today's call is also being 

recorded. If anyone has any objections, you may disconnect at this time. I 

would now like to turn the call 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 Communications and Education. Welcome to the 12th 

CDRH webinar on our PPE Webinar Series. During this webinar, the FDA 

will share information about sterilizers, air purifiers and disinfectant devices, 

including chemical and physical disinfectant devices and ultraviolet 

disinfecting devices. 

Representatives from the FDA and the Occupational Safety and Health 

Administration will be available to answer your questions. Following a few 

opening remarks, we will open the line for your questions related to 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 2

information provided during today's discussion. Now I give you Dr. Cynthia 

Chang, from CDRH's Office of Surgical and Infection Control Devices. 

Dr. Cynthia Chang: Good afternoon, everyone and welcome. As Irene mentioned, this is the 

12th session in our bi-weekly webinar series on personal protective equipment 

or PPE. In prior webinars, we have discussed the regulation of a variety of 

devices, including PPE, face masks and protective barrier enclosures during 

the COVID-19 pandemic. 

Today we will be expanding the scope of the webinar series to include 

sterilizers, disinfectant devices and air purifiers. Dr. Christopher Dugard, a 

biologist in our Office of Surgical and Infection Control Devices, will provide 

an overview of our guidance, which covers our enforcement policy for 

sterilizers, disinfectant devices and air purifiers during the COVID-19 public 

health emergency. 

After his presentation, we will turn to the operator for live Q&A. With that, I 

am pleased to introduce Mr. Chris Dugard. 

Mr. Christopher Dugard: Thank you, Dr. Chang and good afternoon, everyone. As Dr. 

Chang mentioned, my name is Chris Dugard and welcome to this webinar on

our enforcement policy for sterilizers, disinfecting devices and air purifiers 

during the COVID-19 public health emergency. 

During the public health emergency, the availability of technologies that help 

mitigate the transmission of pathogenic microorganisms, have become critical 

to protect healthcare workers and patients. For this reason, FDA released a 

guidance back in March, describing our enforcement policies for sterilizers, 

disinfectants and air purifiers during the public health emergency. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 3

In general, this policy states that FDA does not intend to object to limited 

modifications to the indications or functionality of either FDA cleared or 

approved or non-FDA cleared or approved sterilizers, disinfecting devices and

air purifiers regarding claims of viricidal effectiveness against SARS-CoV-2, 

the virus that causes COVID-19. 

Sterilizers for use in a healthcare facility, are medical devices that are 

regulated by FDA and are intended to render reusable medical devices sterile, 

that is free from viable microorganisms. Sterilizers vary in both construction 

ranging from small tabletop sterilizers to large sterilizers intended for large 

loads and modality. For example, steam, ethylene oxide or vaporized 

hydrogen peroxide. 

FDA evaluates and authorizes sterilizers for marketing with specific cycle 

parameters intended for specific loads. These should also include appropriate 

accessories such as biological indicators, chemical indicator, wraps, trays, et

cetera. 

FDA considers chemical physical disinfectant devices to encompass chemical 

disinfectant solutions used to disinfect medical devices, as well as medical 

washer disinfectors or automated endoscope reprocessors that utilize chemical 

disinfectant solutions or physical processes, for example, thermal, to reprocess 

medical devices. 

UV disinfecting devices are devices that use UVA or UVC light to produce a 

germicidal effect. They are intended to augment disinfection of healthcare 

environmental services after manual cleaning has been performed. Air 

purifying devices are intended for medical purposes, to kill pathogens in the 

air by exposure to UV radiation or remove them through filtration. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 4

Note that some of these products, some of which I will elaborate on later in 

the discussion, have dual jurisdiction with EPA's Office of Pesticide 

Programs. The goal of this policy is to help expand the availability and 

capability of sterilizers, disinfecting devices and air purifiers during this 

public health emergency. 

Note that the policy we will discuss today, will remain in effect only for the 

duration of the public health emergency. Regarding the scope of this policy, 

decontamination of PPE or reprocessing of single use devices using these 

technologies, is outside of the scope. It only applies to those devices that are 

adhering to their typical intended use. 

I would also like to note that none of the devices that are within the scope of 

this policy, have received an EUA authorization. For any EUA authorization,

all of the criteria for an EUA must be met as outlined in the EUA guidance. I 

encourage you to review the EUA guidance for more information. Despite 

this, FDA considers these technologies important in protecting patients and 

healthcare workers from contamination which is the reason we have 

developed this enforcement policy. 

First, I want to provide an overview of the policy in general. During the 

COVID-19 public health emergency it is necessary to maintain an adequate 

supply of sterilizers, disinfecting devices and air purifiers that can facilitate 

rapid turnaround of sterilized or disinfected medical equipment and that help 

reduce the risk of viral exposure for patients and healthcare providers, to 

SARS-CoV-2. 

FDA believes that certain sterilizers, disinfecting devices, and air purifiers 

falling within the scope of this guidance, may help reduce the risk of viral 

exposure based on our current understanding of these devices and SARS-
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 5

CoV-2. Scientifically, we have based this policy on the descending order of 

resistance of microorganisms to germicidal chemicals which is seen here. 

Because sterilization processes render devices free from viable

microorganisms, including bacterial spores and because disinfection kills most 

recognized pathogenic microorganisms, it can generally be inferred that 

sterilization and disinfection should minimize the viability of SARS-CoV-2 

on surfaces and in the air and confined spaces since SARS-CoV-2 is an RNA 

virus enveloped in a lipid bilayer and is considered one of the least resistant 

microorganisms. 

In addition, air purifiers can be designed to filter out virus sized particles. For 

this reason, FDA does not intend to object to limited modifications to the 

indications or functionality of either FDA cleared or approved or non-FDA 

cleared or approved sterilizers, disinfecting devices and air purifiers, when 

making claims of viricidal effectiveness against SARS-CoV-2. 

During the public health emergency, we are providing flexibility on the 

regulatory requirements outlined in Section 4 of the guidance, provided these 

devices and/or modifications do not create an undue risk. These requirements 

include prior submission of a pre-market notification under Section 510(k) of 

the FD&C Act and 21 CFR 807.81 or submission of a pre-market approval 

application or PMA supplement, under section 515 of the FD&C Act and 21 

CFR 814.39, registration and listing requirements in 21 CFR 807 and unique 

device identification requirements in 21 CFR 830 and 21 CFR 801.20. 

You must still comply with all other applicable regulatory requirements if 

they are not specifically addressed in the enforcement policy, including but 

not limited to 21 CFR Parts 820 for quality systems, 806 for reports of 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 6

corrections and removals, 803 for medical device reporting, and Part 801 for 

labeling, except for the sections specifically called out in the guidance. 

As an example, this would apply to a manufacturer that is - that previously 

received 510(k) clearance for a steam sterilizer that is intended for 

sterilization of medical devices in healthcare settings where the manufacturer 

would like to include a statement in the labeling that the device is effective in 

killing SARS-CoV-2 when used in accordance with the validated sterilization 

processes identified in the labeling. 

As another example, this would apply to the manufacturer of a new medical 

air purifier that has not been approved or cleared, and that is effective in 

filtering out dust particles and bacteria, where the manufacturer would like to 

modify the filter mesh size in order to filter out viruses including the SARSCoV-2 virus. 

I want to highlight that any claims of sterilizers, disinfecting devices, or air 

purifiers that are intended to prevent or reduce the risks of hospital acquired 

infections or HAIs, or COVID-19, are outside the scope of this policy. If you 

intend on making these claims, we highly recommend you discuss with the 

agency, to determine what is needed before proceeding. 

I also want to highlight another key phrase of this policy. These devices 

should not create any undue risk. For example, a device that uses a new 

technology that has not been well-characterized or a device that is typically 

intended for a different use that has been repurposed, may create an undue risk 

and could potentially be outside the scope of this policy. 

First, I'd like to go over sterilizers. As described previously, sterilizers for use 

in a healthcare facility, are medical devices that are regulated by FDA and are 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 7

intended to render medical devices sterile, that is free from viable 

microorganisms. This does not include industrial sterilization where FDA 

regulates the process but not the sterilizer or facility, as this is considered part 

of the manufacturing process. 

The table shown here lists the various regulations and associated device types 

and product codes that are within the scope of this policy. Note that this 

encompasses all healthcare sterilizers which the exception of new modalities 

that the agency is not familiar with. 

A typical sterilization validation involves supporting that the sterilizer can 

show adequate lethality to a specified populations of the most resistant 

microorganism. Using the hierarchy of resistance, we can then assume if 

these sterilizers are lethal to the most resistant microorganism they would also 

be lethal to SARS-CoV-2. 

For this reason, these sterilizers are included in the scope of this policy. 

Regarding performance, FDA expects that any modifications including 

changes to the indications or functionality to the sterilizers or to their 

accessories, be designed, evaluated and validated, in accordance with FDA 

recognized standards. 

Note that manufacturers must document changes to their device and their 

device master record and change control records and make this information 

available to FDA if requested, per 21 CFR 820.30 and 21 CFR 820.180. we 

have listed the typical standards associated with the various modalities FDA is 

familiar with, in section 4(a) of the guidance. 

The typical expectation is that a sterilizer and its cycles be validated to an 

SAL or sterility assurance level, of 10^-6 in accordance with these standards. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 8

We have also listed some additional helpful documents like the guidance on 

sterilization and reprocessing, in section 4(c). Regarding labeling, we expect 

that if there are changes to the indications or functions related to SARS-CoV2, this be addressed in the labeling and include information on device 

performance and the potential risks of these changes. 

There should also be labeling clearly delineating FDA cleared or approved 

indications from non-FDA cleared or approved indications. Next, I will 

discuss chemical and physical disinfectants, the regulations, device types and 

product codes of which are listed here. 

As previously described, FDA considers chemical and physical disinfectant 

devices to encompass chemical disinfectant solutions, used to disinfect 

medical devices, as well as medical washer disinfectors or automated 

endoscope re-processors that utilize chemical disinfectant solutions or 

physical processes like thermal, to reprocess medical devices. 

FDA regulates medical device, washer disinfectant devices, liquid chemical 

(sterilants) and high level disinfectants. General purpose cleaners and 

disinfectants such as household products or products which are not 

specifically for use on medical devices, are regulated by the EPA and are 

outside the scope of its policy. 

As with sterilizers, we have listed commonly used FDA recognized standards 

to address the performance of chemical and physical disinfectants in the 

guidance. In addition, we have listed our criteria to support the indicated level 

of disinfection. That is low, intermediate or high level, which should be 

clearly indicated on the labeling. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 9

A low level disinfection process is intended to kill vegetative forms of 

bacteria, some fungi and lipid viruses. This is shown by demonstrating a 

process can achieve a six (log) reduction of common vegetative 

microorganisms, including pseudomonas aeruginosa, staphylococcus aureus, 

E. coli and representatives of the klebsiella (enterobacter) genus. 

Intermediate level disinfection is meant to kill all that a low level process 

would, with the addition of mycobacteria, but not bacterial spores. This is 

shown with a six (log) reduction of common vegetative microorganisms as 

well as a three (log) reduction of an appropriate mycobacteria species. 

High level disinfection is intended to kill all forms of microbial life with the 

exception of large numbers of bacterial spores. This is shown with a six (log) 

reduction of common vegetative microorganisms as well as a six (log) 

reduction of an appropriate mycobacterium species. 

The labeling requirements are similar to the sterilizer requirements, where we 

expect that if there are changes to the indications or functions related to 

SARS-CoV-2 this be addressed in the labeling and include information on 

device performance and of potential risks of these changes. They should also 

be labeling clearly delineating FDA cleared or approved indications from nonFDA cleared or approved indications. 

So while we've grouped UV disinfector devices with chemical and physical 

disinfectants, there are some key differences I'd like to point out. on this slide 

you see the regulation for UV devices. As previously described, UV 

disinfecting devices are devices that use UVA or UVC light to produce a 

germicidal effect. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 10

They are intended to augment disinfection of healthcare environmental 

surfaces after manual cleaning has been performed. They have the same 

requirements as chemical physical disinfectants, in particular our criteria for 

the claimed level of disinfection. 

In addition, FDA recommends that the manufacturer evaluate whether the 

product controls for time, UV radiation dose and intensity of UV dose. 

Validation of the cleaning and disinfection procedure that the device 

augments, should support the claim level of disinfection, be it low, 

intermediate, or high level. 

UV disinfectors also typically produce ozone. Ozone generation should be 

evaluated to ensure it is below the limit established in 21 CFR 801.415. This 

states a device will not generate ozone at a level of .05 PPM by volume of air 

circulating through the device, or cause an accumulation of ozone in excess of 

.05 PPM by the volume of air in the atmosphere of the enclosed space. 

Note that the current limit of ozone exposure for an 8-hour day of industrial 

workers, is .1 PPM per OSHA's requirements. Regarding labeling, UV 

disinfectors also have additional requirements. This includes a caution that 

UV disinfection will reduce the number of pathogens on the device but it will 

not eliminate them completely. 

A statement that the device is an adjunct to currently existing reprocessing 

practices and not a replacement or modification to such practices; a statement 

regarding the time, distance and maximum area over which the device has 

been evaluated for effectiveness; and appropriate UV hazard warning label, 

identification of the expected UV lamp operational life, and instructions for 

procedures on replacement of the UV lamp when needed; procedures to 

follow if the UV lamp malfunctions or fails; a description of the preparation 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 11

of equipment or the room for disinfection; a statement that the equipment 

intended to be disinfected is UV compatible; and identification of the UV 

dose. 

Finally, I would like to discuss air purifiers. The associated regulations are 

listed here. Performance requirements are listed in Section 4(a) of the 

guidance and they include demonstration of a four (log) reduction through a 

combination of capture or destruction of claimed particulates, if intended for 

use against bacteria. So effectiveness against representative gram positive and 

gram negative species. If intended for use related to SARS-CoV-2 

effectiveness against a representative virus. 

If intended for use in areas that have a sterile field or a controlled airflow, a 

risk assessment to address turbulent airflow and/or potential site 

contamination. You'll see here we also have a regulation for air purifiers that 

use UV to kill pathogens. Please note that the same requirements outside of 

the device being labeled as an adjunct, apply to air purifiers that use UV. 

This includes an evaluation of whether the product controls for time, UV 

radiation dose and intensity of UV dose. Assurance that the ozone generated 

falls under the level of ozone specified in 21 CFR 801.415 should also be 

shown. 

Air purifiers within the scope of this guidance are those that are intended for 

medical purposes. Non-medical air purifiers are not within FDA's purview. 

The term for medical purposes, is kept intentionally general. We will review 

the claims being made for the device as well as its intended operating 

environment, to determine if an air purifier is making a medical claim. I will 

provide some examples. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 12

Simply listing the microorganisms the device is effective against, or the 

particle sizes it can filter, does not necessarily make the device a medical 

device. Reduction or prevention of infection from those microorganisms 

however, is a medical claim. Protection against these microorganisms would 

also be considered a medical claim. 

Providing specific health benefits is considered a medical claim. Regarding 

this policy, claims of lethality against SARS-CoV-2 which is the pathogenic 

organism, is an acceptable claim. However, treatment or prevention of 

COVID-19 which is the disease state, is not an acceptable claim. 

As noted earlier, healthcare associated infection claims are outside the scope 

of this policy. If you are uncertain as to whether a claim you are making is 

considered a medical claim, we encourage you to reach out to the agency for 

feedback. 

So we are getting to the end of the presentation part of this webinar. Here are 

some useful resources including the sterility guidance, the reprocessing 

guidance and liquid chemical sterilant high level disinfectant guidance. I 

encourage you to review these. 

And that concludes my presentation and we will now take questions. And 

while we're opening the line and you're thinking about your questions, I 

thought I would get this started with a couple of frequently asked questions. 

So I know I just went over this in my last slide, but we've received a lot of 

questions about it, so I think it bears - we often receive a question about what 

claims constitute a medical claim, especially in the context of air purifiers. 

So to reemphasize, examples of nonmedical claims include listing the 

microorganisms, the device is effective against either by killing the 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 13

microorganisms or filtering them. And this also includes listing specific 

particle sizes the device can filter. 

Removal of airborne microorganisms, pollutants, contaminants or pollen. 

And if it is intended for general use, such as on surfaces and non-healthcare 

environments, these are all examples of non-medical claims. Examples of 

medical claims include stating it's for medical purposes; reduction or 

prevention of infection; prevention of any adverse health effect such as 

alleviation of allergies, asthma, et cetera; or if it claims to provide any specific 

health benefits; or if it is for use on another medical device. 

And again, in the context of this policy, a claim that the device can kill or 

filter SARS-CoV-2, which is the virus, is an acceptable claim within the scope 

of this policy. A claim that the device can treat or prevent COVID-19, the 

disease state SARS-CoV-2 causes, are not within the scope of this policy. 

So we also received quite a few questions about the regulatory requirements, 

so we've - so the question we receive often is do I need to comply with 

regulatory requirements that are not listed in the enforcement policy for my 

device, such as 21 CFR 820 for quality systems, 806 for reports of corrections 

and removals, 803 for medical device reporting and 801 for labeling? 

The answer is yes. If you are marketing a medical device, you must comply 

with all applicable regulations and requirements. Our enforcement policy 

identifies the specific areas for which we do not intend to object if you do not 

comply. However, all other requirements are still in effect. 

Now with that, I will pause there and see if we have any questions from the 

audience. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 14

Irene Aihie: Operator, do we have any questions on the line? Please standby as we wait on 

our operator. She is gathering participants and their questions now. 

Dr. Christopher Dugard: Great. Thank you. Well while we're waiting I can go over one 

more frequently asked question. So again, this is another topic that I 

mentioned in my presentation, but it bears repeating. Is my sterilizer, 

disinfecting device or air purifier that uses a new technology, within the scope 

of the guidance? 

If your device uses a new technology or involves changes to an existing 

medical device, we highly recommend you reach out to the agency for 

feedback on whether your device would still be within the scope of the 

guidance. This goes for any aspect of any device that may be within scope of 

the policy. If you suspect something may create an undue risk, please reach 

out to the agency. 

Irene Aihie: We will take our first question. Operator, I believe you may still be muted. 

Dr. Christopher Dugard: Well I can discuss one more quick question. Another frequent 

question we receive is can I decontaminate PPE or other single use devices? 

And the answer is unless the specific device you are working with has 

received an EUA to do so, then no. Some healthcare sterilizers have received 

an EUA authorization to decontaminate N95s, but indicating any of the 

devices that are in the scope of the guidance for decontamination of PPE, 

requires an EUA. 

Please refer to FDA's Web site for those healthcare sterilizer models that have 

received EUA authorization for decontamination of N95s or other PPE. 

Unless the device you are working with has EUA authorization, the device 

should continue to be used as originally indicated. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 15

For example, this means a healthcare sterilizer can continue to sterilize 

reusable medical equipment and make claims that it is effective at killing 

SARS-CoV-2. However, the same healthcare sterilizer cannot reprocess 

single use devices like N95s, surgical gowns, etc. 

Irene Aihie: Thanks, Chris. I believe we have (Alison Comioma), who is ready to ask a 

question. Go ahead, (Alison). 

(Alison Comioma): Can you hear me? 

Irene Aihie: Yes. 

(Alison Comioma): Okay. Hi. Thanks so much for putting this webinar on. I really 

appreciate it. And Chris, this is excellent information. My question is what 

sort of documentation - like level of documentation should be prepared to 

support a device that falls within this guidance document, as we continue to 

put together the quality system per 21 CFR 820? 

I know you said, you know, it is good to have that FDA won't, you know, 

they're not going to enforce that general control at this time, but yes, what 

would be acceptable just for our internal purposes? 

Dr. Cynthia Chang: Hi. This is Cynthia Chang. So thank you for the question. The question 

is about the level of documentation that is needed under 21 CFR 820 for 

making changes in alignment with the guidance. And to answer that question, 

I would say that our enforcement policy is not making any changes to 21 CFR 

820 and the quality system regulation. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 16

So for the purposes of making any changes in accordance with this 

enforcement policy, you should continue to follow 820 and the quality 

systems regulation as you would, under normal circumstances. Thank you. 

(Alison Comioma): Okay. What I'm - sorry, can I have a quick follow up? Is there - the level 

of - would an internal memo to make sure that we fulfill each one - the 

appropriate sections of the guidance document just be an added document that 

we should have in place? 

Dr. Cynthia Chang: So the question is regarding whether a memo to address how each of the 

items are addressed under 820, if that would be sufficient. And for the 

purposes of the enforcement policy and our guidance, we do not have any 

specific recommendations on that. I will turn to my colleagues and ORP and 

CDRH to see if there is any additional comments on documentation of 

changes that might be appropriate under 21 CFR 820. 

(Cesar Perez): Yes. Good afternoon. This is (Cesar Perez) from the Office of Regulatory 

Programs. I believe what Cynthia - what you provided is correct. I don't 

think there's any specific guidance on what type of accommodations you need 

to provide in - in order to state that you are fulfilling all the requirements in 

the enforcement policy. 

But it would be important to provide that information as part of your regular 

process. And maintain files or a memorandum potentially, to be able to state 

that you are fulfilling those requirements. But there isn't any specific. It's up 

to the (firm) to do that. Thank you. 

(Alison Comioma): Okay. Thank you. Thank you, Dr. Chang. I appreciate it. 

Dr. Cynthia Chang: Thank you. We could take the next question, please. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 17

Irene Aihie: Okay. We have another caller. Caller, your line is open. I can't see your 

name because our operator is having some issues on her line. But if your line 

is open, please go ahead with your question. Caller, or operator, can you hear 

us? Or are you on mute? Our operator is contacting me and she's saying that 

she's speaking; but we cannot hear you, Operator. Okay. 

I am showing that there are no further questions. Before I close out, Chris or 

Cynthia, do you have any closing remarks? 

Dr. Cynthia Chang: Hi. This is Cynthia Chang. Just to thank all of our audience for dialing 

into the call today. As we noted, if you do have a question about a specific 

device or situation, you may feel free to use the email address on the screen 

now, to send your questions to us. And let me check with Chris, to see if there 

are any final comments from him. 

Irene Aihie: One second, before Chris gets started. Our operator just mentioned that we 

have a question from someone named (Mike). So I'm going to go ahead and 

pause there. And (Mike), if your line is open, please proceed with your 

question. 

(Michael Marrow): Hi. This is (Michael Marrow). I hope I'm the open line. So is it - can you 

guys hear me? 

Irene Aihie: Yes. We can hear you, (Mike). Thanks. 

(Michael Marrow): Okay, good. Thanks. And thank you for putting on this webinar and 

thank you, Chris, for the slideshow and examples. They were really helpful. I 

Have a quick example. If I'm - have a company that has new technology for 

killing or filtering virus sized particles or specific to SARS-CoV-2 but they 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 18

keep their claims in that realm of killing or filtering in non-medical, is an 

EUA required or is that outside the scope of this guidance? Thanks. 

Dr. Christopher Dugard: I can answer that question. 

Dr. Cynthia Chang: Hi (Michael). This is - this is Cynthia. Let me just repeat the question and 

then I'll turn it over to Chris. So the question is about if a device has specific 

claims and whether that needs an EUA or whether it could be covered under 

the scope of the guidance. 

And let me just remind everyone that in general, we are providing high level 

comments today and in terms of the specifics of any particular device, you 

know, that's something that we would advise you to look into the details of 

our enforcement policy before making a final determination and reaching out 

to us for any specific issues. 

However, in general, let me turn it over to Chris Dugard, to see what 

comments he has about this question. 

Dr. Christopher Dugard: Thank you, Dr. Chang. At a high level, well first you mentioned 

that it would be a new technology. And as I mentioned in my presentation, 

we are concerned with devices that might create an undue risk. 

And since this is a new technology and, you know, we're speaking generally 

now, I encourage you for that alone, to reach out to the agency so that we can 

work with you and determine whether or not that technology does represent or 

does present any undue risk. 

Regarding EUAs, for any device where, you know, it might be outside the 

scope of this policy or you just think you have a technology that might fit 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 19

within the EUA paradigm, again we highly recommend you review the 

guidance and ensure that the technology that you're trying to support fulfills 

all of the criteria outlined within that guidance. 

Without knowing more about the device, I don't think I can provide too much 

more feedback. But I do hope that answered some of your question. 

(Michael Marrow): Yes. I appreciate that. And I wanted to keep it as general as possible. 

We'll probably follow up. Thanks a lot. 

Dr. Christopher Dugard: Thank you. 

Irene Aihie: Okay. It looks like we have no further questions. Chris, I believe I cut you off 

before you were about to make some closing remarks. Is that still the case?

Dr. Christopher Dugard: Thank you. Yes. I just wanted to thank the audience for attending 

and we look forward to working with all of you if you have any devices that 

you'd like to get any feedback on. 

Irene Aihie: Thank you so much, Chris. Again, thank you to everyone. This is Irene 

Aihie. We appreciate your participation and thoughtful questions. Today's 

presentation and transcript, will be made available on the CDRH Learn Web 

page at www.FDA.gov/Training/CDRHLearn, by Wednesday, December 16. 

If you have additional questions about today's presentation, please use the 

contact information provided at the end of this live presentation. As always, 

we appreciate your feedback. Following the conclusion of today's webinar, 

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

experience. 
FDA Webinar

Moderator: Irene Aihie

12-08-20/12:00 pm ET

Page 20

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. 

END