FDA

Moderator: Irene Aihie

05-15-20/1:00 pm ET

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FDA Townhall with NIH and VA: 3D Printed Swabs

Moderator: Irene Aihie

May 15, 2020

1:00 pm T

Coordinator: Welcome and thank you for standing by.

At this time all participants are in a listen-only mode until the question-andanswer 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 now like to turn the conference over to Irene Aihie. Thank you. You 

may begin.

Irene Aihie: Hello. Welcome to today's FDA town hall. I am Irene Aihie of CDRH's Office 

of Communication and Education.

Today we will discuss the production and use of 3D printed swabs during the 

COVID-19 public health emergency. This is a collaboration between the 

FDA, the Department of Veterans Affairs (VA) Innovation Ecosystem and the 

National Institutes of Health (NIH) 3D Print Exchange.
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The FDA's policy for diagnostic tests for coronavirus disease 2019 during the 

public health emergency was issued on February 29, 2020 to help accelerate 

the availability of novel coronavirus tests developed by laboratories and 

commercial manufacturers for the duration of the public health emergency. 

This guidance was updated on March 16, May 4 and May 11, 2020.

Today Timothy Stenzel, Director of the Office of In Vitro Diagnostics and 

Radiological Health in the Office of Product Evaluation and Quality, here in 

CDRH at FDA, will open this discussion on 3D printed swabs during the 

COVID-19 public health emergency. He is joined by other members of 

CDRH, FDA as well as NIH and VA.

Following the presentation, we will open the line for your questions related to 

information provided during the presentation.

Now, I give you Tim.

Timothy Stenzel: Welcome and thank you joining us today for this 3D printed swab virtual 

town hall. This represents a collaboration between the FDA, the VA and the 

NIH. We are keenly aware of spot shortages of a number of supplies and 

reagents and are looking at maximum regulatory flexibility of these stated 

needs during these unprecedented times during this pandemic.

We welcome input in collaboration with all to help address these needs. This 

virtual town hall is just such an example of outreach and collaboration and 

interaction. And we have an amazing group of subject matter experts on the 

call today.

We look forward to a very productive meeting and a very interactive meeting. 
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And with that, I turn it over to Dr. Sara Brenner.

Dr. Brenner: Thank you, Tim. This is Sara. And I thank everyone for being on the call 

today. Many folks I'm sure who have dialed in have been engaged with 

dialogue with Tim and I through the OIR town halls, which have been 

happening for many weeks and where you have heard mention of 3D printed 

swabs.

I am joined today by other colleagues across FDA including members of our 

team in the Office of In Vitro Diagnostics. We also have the Office of 

Strategic Partnership and Technology Innovation, the Office of Chief 

Scientist, the Office of Science and Engineering Laboratories as well as our 

fantastic colleagues from the National Institute of Allergy and Infectious 

Diseases at NIH and the Veterans Health Administration Ecosystem.

So the goals of this town hall today, and then we'll get into this, are generally 

to provide an engagement and dialogue opportunity with the community. 

We're aware, as Tim mentioned, that there are many folks who are looking for 

ways to engage and to help address shortages particularly through an 

innovative means of making swabs.

We'd like to also discuss the great work being done under our collaborative 

Memorandum of Understanding with our federal partners at NIH and FDA 

which focuses on 3D and additive manufacturing broadly.

We'll also discuss considerations that experts in these agencies as well as the 

community believe are important for swab use in COVID-19 testing. We 

would very much like to recognize the important work being done by 

everyone who has dialed in and all of the folks who have reached out to us 

and asked questions that you were seeking answers to.
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To wrap-up the call, we will have a brief Q&A, and then we would like to 

point stakeholders toward a path forward for further engagement.

So with that, I'm going to turn it over to Matthew Di Prima at the FDA in the 

Office of Science and Engineering Laboratories who will provide some 

insight on the federal partnership under our MOU.

Dr. Di Prima: Thank you so much, Sara.

As Sara mentioned, I am going to briefly discuss the Memorandum of 

Understanding titled Rapid Response to COVID-19 Using 3D Printing which 

is between the National Institutes of Health (NIH), the Food and Drug 

Administration (FDA), and the Veterans Administration (VA).

So for a complete background, in late March there was a significant 

groundswell of support from the additive manufacturing and 3D printing 

communities to address COVID-related shortages and the community was 

really looking for help in understanding how they could engage with health 

partners and address the supply shortage.

And so to support the community, the VA, NIH and FDA entered into this 

Memorandum of Understanding (MOU) to create a way for legally marketed 

products to be presented to the community and then to ultimately connect 

manufacturers with those with clinical needs.

So the very first goal of the MOU was in fact to connect health care 

organizations with shortage needs to manufacturers who have the capacity to 

address those needs. We are hoping to be able to share 3D printing files as 

well as lessons learned with the community to make sure that these products 
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can be made as widely and as effectively as possible.

We are working to do consultation on models, testing and practices and then 

engage with the community to make sure that the products being printed meet 

the clinical needs.

We wanted to provide a bridge for discussion regarding clinical and 

community safety for products that aren't typically approved by the FDA. So 

these were for legally marketed products that don't meet FDA pre-market 

approval but community and clinical locations still wanted some level of 

understanding of how these products would perform.

One is to provide a shortened list of these 3D printable products so, again, 

manufacturers and clinicians could understand what was available to the 

community to address their specific needs, or for the manufacturing side, what 

products they could manufacture.

And we're also very interested in outreach and education to both the 

manufacturing and the health care community about alternative ways to 

address medical products during the pandemic as well as to engage with 

manufacturers who weren't traditionally used to manufacturing medical 

products.

So for each agency there are a series of specific roles. The FDA under the 

MOU provides engineering and support in evaluating and developing tests for 

3D printed products or providing insight into regulatory the framework and 

requirements for the range of products being looked at under an MOU as well 

as to support community engagement and outreach to ensure health care 

workers and patients have access to key medical products during the COVID 

pandemic.
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NIH, through their 3D Print Exchange, agreed to host the repository of 

products to be printed during the COVID response. They cataloged and 

organized files so users can easily access the data they need to determine the 

appropriateness of their situation.

And they've been actively developing communication and print resources for 

the print exchange community to explain the different regulatory requirements 

around some of these products as well as best practices to make them.

The Veterans Health Administration has been providing key clinical and 

engineering expertise in the evaluation process. Significantly they've been 

doing a lot of clinical evaluation of these designs to make sure that face masks 

and face shields and other products will work in a clinical environment.

They've been also coordinating with other groups for clinical testing as well as 

some of the materials testing that they perform and they've been key in 

providing communication and feedback back to the designers about potential 

improvement to the process.

Now not mentioned in the Memorandum of Understanding but a key partner 

with us has been America Makes, which is a public-private partnership of 

which the FDA is a member. And we've been working with America Makes to 

partner with industry as well as working to connect industry with the clinical 

needs going back to our very first bullet point for the MOU.

They've also been key in coordinating with other government and industry 

bodies as we've been working to engage in greater manufacturing 

communities as well as a broad number of government entities with 3D 

printing capabilities.
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And they've also been hosting outreach and educational events to increase the 

impact of the work. So some key specifics on how this effort has performed, 

to date America Makes has matched over 170,000 pieces of equipment, most 

primarily PPEs between manufacturers and clinical sites. And then they have 

over 400 manufacturers who have logged into their website and provided 

information on their manufacturing capabilities.

On the NIH Print Exchange side, we've received almost 460 designs, of which 

18 have passed a clinical assessment and 14 other designs have been found 

appropriate for community use. And so far there have been 34 devices with 

significant warnings based off of their performance.

In terms of the NIH print exchange, the repository, that COVID-19 page, has 

been viewed almost 200,000 times since launch. A total collected view of all 

models has exceeded 1 million views. And the top ten designs have been 

downloaded over 70,000 times.

Some key thoughts as we're moving forward is it appears that 3D printed 

swabs are a good candidate for this pathway given the legally marketed 

classification for them as well as the COVID related shortage needs.

And with that, I would like to introduce Dr. Phillip Cruz of the National 

Institute of Allergy and Infectious Diseases at the National Institutes of 

Health.

Dr. Cruz: Thank you, Matthew. So if I could have the next slide, please. Okay. So I'd 

like to review briefly the history and the role of the NIH 3D Print Exchange 

with this effort. And it was started in 2013 and it is currently directed by Dr. 

Meghan McCarthy, who unfortunately was not able to be here today.
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And if I could have the next slide, please. This slide just gives a brief 

background on the place of the 3D Print Exchange within NIH. It's actually 

managed out of the National Institute of Allergy and Infectious Diseases, 

which is one of the 27 institutes and centers at NIH. This is the one that is 

directed by Dr. Anthony Fauci.

And our group is actually part of the IT Department for that institute, the 

Office of Cyber Infrastructure and Computational Biology where we have a 

group of developers and scientists. And we do software development project 

management and research consulting.

And could I have the next slide, please? So back in 2013 there was a 

recognized need for a place for storing and creating and sharing biomedical 

3D models for the purpose of 3D printing. And as a result of that meeting, the 

NIH 3D Print Exchange was born.

And this is an example of some of the kinds of content that's available on the 

site, including the first two models shown here, which are part of the current 

SARS COVID-2 collection of protein and viral structures from experimental 

data that are on site. And you can see the URL for the home page there at the 

top.

Next slide, please. So as a result of the MOU and as Matthew just described, 

there have been a large number of submissions of 3D models for printing to 

the site. And a couple of examples of things that are available are shown on 

this slide.

And if I can go to the next slide, please. So the URL at the left shows the 

collection, the latest of the COVID-19 response on the site. And at the right is 
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a screen capture of that particular page showing some of the models that have 

been reviewed for clinical use and then assistance for both our creators, 

manufacturers and users of the site on how to best use it and how to contribute 

to it.

And so this is kind of the main landing page related to the supply chain 

response effort. And as Matthew mentioned earlier, it has had quite a bit of 

interest as indicated by the stats that you mentioned.

Next slide, please. So I'm not going to go into the specifics for the site use any 

further except to mention the one about two-thirds of the way down. We've 

had a 1,390% increase in visitors compared to the previous period. So this has 

made a huge impact on our size and hopefully we're making an impact on the 

COVID-19 response as well.

Next slide, please. So if you do go to the site to contribute some data or 

contribute models, you would go to what we call the share page. And this is 

an example of what that looks like. Each of those tabs allows you to provide 

all the information that's necessary to go along with your model and allows 

you to update the 3D printable files that you can then share on the site.

And then if we go to the next slide, please. So if you go to the top tab, the 

general information tab, because I'm not going to go through all of them. Just 

to show you that there's additional field that you can fill out with the metadata 

associated with your submission.

For instance, for the device used you could use general equipment or adapter. 

And the more information that you can provide the better it is for looking at 

and for others to evaluate your submission to the site.
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Next slide, please. So the current thinking for swabs and the clinical 

considerations that are on the slide will be on this page here, this URL. This 

page is not live yet. It should be live later today and it will be updated 

continuously as the thinking on swabs continues to evolve. So just keep in 

mind that this is the place to go for the current information that we will have 

on the slide.

Next slide, please. I just want to thank all of our partners in this effort. It's 

been a fantastic team and a fantastic experience for all of us.

And next slide, please. And if you have any questions related to the site itself, 

send them to 3dprint@nih.gov.

And now I'd like to introduce Dr. Beth Ripley, who is the director of the 

Veterans Health Administration 3D printing networks at VA Health Care 

Systems.

Dr. Ripley: Thank you, Phil.

As we've been saying, this partnership has really been about acting fast to help 

front line staff, concerning COVID-19, have access to the safest and most 

effective 3D printed personal protective equipment and other medical 

supplies.

The role that VA is playing in this partnership is really in the clinical testing 

of the 3D printed design. So the 3D printed network prints the parts. We test 

the safety and clinical efficacies. This is all done in collaboration with VA 

front line medical providers and staff.

As the largest health care system with thousands of researchers embedded in 
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our hospitals and hundreds of innovation specialists, we have both the 

scientific knowledge and agility and flexibility to anticipate novel solutions 

and react accordingly.

And I believe we all on this call recognize that unanticipated disruptions in 

supply chains can leave health care systems vulnerable, so we have a larger 

general interest in the concept of digital stockpiling of device designs that can 

be called on during the current or future crises.

So why nasal swabs? It's really important that we determine the effectiveness 

of nasal, nasopharyngeal or anterior nares swabs to ensure that we have 

appropriate clinical information to care for our patients as false positive and 

false negative results could introduce errors in treatment plans and place 

patients and staff at unnecessary risk.

Further, there's no clear precedent for 3D printed nasal, nasopharyngeal and 

other swabs. There is some great initial work and studies out there that have 

looked at the effectiveness. But we felt that there was need for additional data 

around this topic.

So what role does VA have with respect to swabs? What we're hoping to do is 

leverage what we've done so far within the MOU, which is come up with 

clinical protocols that assess the effectiveness of 3D printed products for use 

in hospitals such as face shields, 3D printed face masks and other accessories.

Really our intent is to consider all of the unique features that go into 3D 

printed swabs and develop the testing protocol that will demonstrate 

equivalents to the standard of care. This protocol will be shared publicly under 

the spirit of the MOU.
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I do want to be clear that our intent is not to endorse any specific swab design. 

Instead we're really looking to create a framework for assessment of all swabs 

that fit into this unique category. We also recognize that swabs are made with 

different printing technologies, materials, designs and sterilization processes.

We are endeavoring to provide a protocol that takes these variabilities into

consideration. We believe this study protocol could be useful beyond the 

COVID-19 pandemic as we may face similar scenarios in the future.

We also understand that although 3D printing technologies present certain 

challenges, most notably the lack of years of scientific data on the trial uses in 

medicine, we view this as a great opportunity to contribute to the knowledge 

in the field that will grow this emerging technology in medicine.

When thinking about this protocol, we will be considering certain design 

characteristics, which will be published on the NIH 3D Print Exchange. And 

we can talk about those more in the Q&A, but for example, we're thinking 

about things such as, is the swab size and shape sufficient for passing through 

the nasal cavity and reaching the intended sampling location?

Is it unobtrusive enough to minimize the risk of epistaxis or discomfort to the 

patient? Is it able to effectively absorb the sample, the elusive sample and not 

interfere with the testing assays and more?

So with that I'd like to turn it over to Sara Brenner from the FDA Office of In 

Vitro Diagnostics.

Dr. Brenner: Thank you, Beth. And I am back. I'm going to just briefly discuss some things 

for consideration that hopefully provide a bit of a response to the numerous 

questions, hundreds of emails and other types of outreach, that we are aware 
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of on this topic.

In terms of technical considerations around the development and evaluation of 

3D swabs for clinical use as described by Beth and Phil, our hope is that this 

collaboration will lead to more clarity in this area as our agencies continue to 

work together and with experts in the community.

So as we move on from this call, we look forward to discussing various points 

of view on technical considerations in the spirit of sharing expertise as part of 

engaging stakeholders who are working diligently to address pertinent needs, 

including supply shortages during this public health emergency.

So we'd like to briefly outline some of the considerations that may be valuable 

to provide consistency in developing and validating 3D printed swabs in this 

case.

To be clear, we are not providing any regulatory determinations or guidance 

on this call today. Rather, we are introducing these topics for continued 

discussion amongst our federal colleagues and the larger stakeholder 

community.

Nasopharyngeal and nasal swabs, also referred to as absorbent tip applicators, 

are generally provided sterile and individually packed for single use. Sterility 

packaging and labeling are important considerations for these devices.

As these devices have not traditionally been produced using additive 

manufacturing, there may be unique considerations for the new 3D printed 

version. FDA's guidance document on "Technical Considerations for Additive 

Manufactured Medical Devices" includes considerations specific to 3D 

printing, such as materials, controls, post-processing and overall process 
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validation.

Since swabs are used internally, it is important to consider the 

biocompatibility of the materials, including any potential effects on the 

material from the process of sterilization. Material considerations may include 

a history of safe use, including any prior verification that a material is noncytotoxic, non-irritating and non-sensitizing.

It's also important to consider the mechanical properties, flexibility and 

durability of the 3D printed swab after sterilization. While there are currently 

no testing standards for swabs, there are existing standards for tensile, 

torsional and flexional testing that could be considered when assessing a 

swab's mechanical properties.

Since 3D printed swabs may have different functional properties than 

traditionally manufactured swabs, it is also important to consider the 

analytical and clinical applicability as has been previously described.

It's important that the swabs be able to adequately collect clinical specimens 

without damaging tissue and be able to sufficiently collect, retain and elute 

clinical specimens for downstream analysis.

It's also critical in this case that swabs be compatible with and not negatively 

affect representative downstream assays such as PCR or antigen tests. We are 

excited to continue discussions on these topics through this collaborative 

effort. And with that, I would like to turn it over to James Coburn in the 

Office of the Chief Scientist at FDA.

James Coburn: Thanks very much. So my role here is to give a little bit of information about 

the future engagement and next steps for those who want to take them with 
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how you can engage with us and the other federal agencies involved.

First of all, as you see on the screen, there are websites for the partners here of 

the MOU, and America Makes also has a website for COVID-19. It is 

americamakes.us/COVID19, all one word. And those websites provide all of 

the updated resources on what designs are in the pipeline, what are the 

properties that people are following, and what the community's best practices 

are as collected by that MOU community and the invited people who are 

involved in that community.

If you are looking specifically to engage on things in the nasal swab arena, 

you can follow that same pipeline that Dr. Cruz outlined for the NIH website 

and look at existing best practices around design testing for those swabs. 

There should be a nasal swab link from the general link that he posted.

Soon there will be a collected wisdom document where just the general design 

considerations, technical wisdom and other things from experts and 

stakeholders that people have written in and people have talked to that will be 

on that website, so that you know where your benchmarks are as well as all 

the standards. So we've listed all those standards there.

And as Dr. Ripley mentioned, there will be an example protocol from the VA 

that they will be following and they will give for other people to follow as 

well.

So once you have those items in your package, essentially, you can post that 

information to the NIH website, the design, the test data, the reports.

Unlike some of the other images and designs that are on there, you do not 

have to post your 3D design or printable file on there, depending on what you 
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want to do as long as there is kind of a description of that, maybe a picture of 

it, and the test data so people on the backend will be able to look at that, 

evaluate to see if that design is essentially conforming with or compatible to 

traditional swabs. And then give it that clinically reviewed badge on the 

website.

If you haven't been to the NIH website, you will see that they are tested. There 

are prototypes. And then there are clinically reviewed badges. So that will 

give it a little extra official marker there.

The contact and other information on how someone can use your design 

should also be included in that. We want people to be able to use it or you 

want people to be able to get in contact with you so they can connect to you. 

So post that on the NIH website.

Also consider connecting with the America Makes group if you are a 

manufacturer. They have a manufacturer button. You say what you can do. 

What you have the capacity to do. And they can connect you with health care 

workers who need that resource.

Lastly I would say that additional specific information on the data checklist 

that NIH and VA and the MOU is going to want to see to make that clinically 

reviewed badge a possibility is going to be posted soon as well as physician 

workflow and comparative criteria for the traditional swab.

That way everybody will just have an open playbook. It's really about making 

things available to the community and opening up the playbook so that we can 

get things done quickly, efficiently and still safely.

So stay tuned to those websites for updates. You can see them right here. If 
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you have specific questions, you can, of course, contact the FDA at 

COVIDmanufacturing@fda.hhs.gov.

The NIH Print Exchange can be contacted at 3Dprint@nih.gov. And you can 

go to their website and you can also go to the americamakes.us/covid19 

website, which has a form. You can contact them as well. With that, I believe 

the next up is to turn it back to the operator to have question and answer time.

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. It will take a few moments for the questions to come 

through. Please stand by.

Our first question comes from (Jim Linder). Your line is now open.

(Jim Linder): Thank you very much. The statement was made that one may need to 

demonstrate equivalents to the current fiber-based swabs. How will you 

handle the situation if the 3D printed swabs actually collect more cells?

Dr. Brenner: This is Sara from FDA. That's an excellent question. And I guess we would 

look forward to the possibility that 3D printed swabs might actually outperform conventional swabs. I can't say specifically how we would handle 

that.

But I would strongly encourage you to conduct testing and engage with us 

through the NIH and FDA, as has been described, to collect that data and so 

that we can all learn together about how the performance compares to the 
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conventional swab.

(Jim Linder): Thank you.

Coordinator: Our next question comes from (Nicholas). Your line is now open.

(Nicholas): Hi. Yes. This is a bit of a two-parter. I represent a research group at the New 

Jersey Institute of Technology. We recently posted a design to the NIH form. 

Mostly I heard the term nasal swabs and rarely pharyngeal. Is it a certainty 

that we're working away from throat swabs and looking just toward nasal 

swabs?

Dr. Brenner: This is Sara from FDA. Was the question, are we looking at nasal and 

nasopharyngeal versus what was the other type of swab you asked about?

(Nicholas): No. Are we looking at just nasal or are we moving away from the possibility 

of throat?

Dr. Brenner: I'm afraid I missed that last part again. However, from our perspective I don't 

think we're indicating a movement towards or away from any particular type 

of swab. That's sort of a different question.

But I would encourage you to investigate and proceed with the research and 

development of any of the swab alternatives for the collection devices that are 

being used, which do include nasopharyngeal, pharyngeal and nares swabs.

(Nicholas): That's good to know because my follow-up to that is the design posted is the 

design for throat only, and I was wondering if there was any way we could 

follow-up with getting that verified because we've gotten some great research 

back on sterilization processes, promising stuff, so we were wondering if there 
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was any way to follow-up and move forward with that.

Dr. Brenner: Okay. I understand now. Yes, that's been a topic that we're exploring, you 

know, all different types of collection devices. So, yes, I would encourage you 

to reach out with regards to submitting your designs to NIH. And I believe 

that we would look forward to receiving any additional data and information 

from research.

(Nicholas): Is there an email that's best to follow-up with if it's already been submitted?

Dr. Brenner: I believe that was the one that Dr. Phil Cruz put up and was previously 

mentioned. So could we provide that email again verbally?

Dr. Cruz: Yes. It's 3Dprint@nih.gov.

(Nicholas): All right. Awesome. I do have it down. So I will follow-up right after this call. 

Thank you very much.

Dr. Brenner: Great. Thanks.

Coordinator: Our next question comes from (Richard Nicholas). Your line is now open.

(Richard Nicholas): Yes. We are already have a swab that has already been tested and 

reviewed at Harvard Medical. We have all of the data supporting it and 

everything. It's got 180 degrees worth of bend to it. The product itself - the 

material is already being used medically. It's registered with the FDA.

How do we go about getting that product to the NIH so that way the 

government knows that product is now available?
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Dr. Brenner: Great. Phil, would you like to take that for NIH?

Dr. Cruz: Yes. Just go to the page that I mentioned earlier, the share page on the site. 

And you will be able to make a submission to the site just by entering all the 

information there.

(Richard Nicholas): Because we currently have the ability to ramp up to a million swabs a 

month. And so we're looking at - we're just looking at the proper areas to go 

through.

James Coburn: This is James Coburn. You may also want to put that capacity on the America 

Makes manufacturer site so that people that are not just on the government 

side of things know that you have that capacity available.

(Richard Nicholas): Thank you very much.

Coordinator: Our next question comes from (Mathew White). Your line is now open.

(Mathew White): Hi. So I got pulled away a little bit. But we have a file for a swab that's been 

tested and approved. But we are only ISO 1345 compliant and not certified. Is 

there any way to provide you without being officially certified by ISO

standards?

Dr. Brenner: This is Sara from FDA. What I would encourage you to do is reach out to 

perhaps all of us simultaneously, NIH, VA and FDA, with regards to that 

specific question on ISO standards and what your specific manufacturing 

capability is and we will try to get you an answer.

(Mathew White): Okay. Could you read off those emails again?
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Dr. Brenner: For FDA, COVIDmanufacturing@fda.hhs.gov. The NIH was 

3Dprint@nih.gov and I'm not sure, Beth, if you provided and email for VA? If 

you want to now, you can. Otherwise you can just send to the two of us and 

we'll loop in VA.

(Mathew White): Okay. Can you...

Dr. Ripley: If you could just loop us in that would be great.

Dr. Brenner: Okay. Will do.

(Mathew White): What was the very end of the last one, covidmanufacturing@fda.

Dr. Brenner: hhs.gov.

(Mathew White): hhs.gov, okay. Perfect. Thank you.

Coordinator: Our next question comes from (Ben Glendell-Ingler). Your line is now open.

(Ben Glendell-Ingler): Hi, everyone. Thank you for the time today and the information. We've 

kind of been at this for a little while with a number of you who are on the call. 

A few observations is this approach seems organized with the major 

community in the open source approach where the NIH and the VA are taking 

on responsibilities that are typical of the medical device manufacturer.

And for PPEs, the FDA has raised emergency enforcement policies that waive 

many regulations such as 21 CFR Part A 20 and GMP. This type of guidance 

documentation has provided a clear benchmark for the risk to benefit of use of 

product manufactured in compliance with this guidance during the COVID-19 

crisis. And I think this continues to not be the case for NP swabs.
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Now I think there's a big difference between interest meaning page views and 

impact and 170,000 pieces of PPE is really great. And I applaud you all for 

your efforts and that. But the demand is much greater and we've needed swabs 

for over two months. And we need swabs now.

So at the end of the day, you know, the swab is a Class 1 exempt device. So is 

what was announced today in your approval pathway an opportunity to 

collaborate and accelerate work that is done already? And are you going to 

take action against manufacturers for doing the traditional pathways that are 

already distributing?

Dr. Brenner: This is Sara from FDA. Thank you so much for sharing those thoughts, 

observations and comments. And you're right, we are aware of the need and 

some of the concerns you've just raised. We've been also hearing about this 

for a while.

So I want to acknowledge that, and I want to thank you for your patience as 

we're working through how to most appropriately respond and aid the 

community.

Unfortunately today we are not providing any regulatory determinations or 

guidance specifically. But I do encourage you to stay tuned. And we are 

hopeful that we will be able to more directly answer your questions in the very 

near future.

(Ben Glendell-Ingler): Thank you. And if one of our manufacturers already has VA Hospitals as 

customers, are they in the system and is the VA already aware of these or do 

we need to add them to the portals that have been developed?
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Dr. Brenner: I would ask Dr. Beth Ripley to address that from VA's perspective.

Dr. Ripley: Yes. So this is Beth. From the VA's perspective we are aware of the need for 

swabs and the inputs within our hospitals for utilizing swabs. What we want to 

do as an organization is ensure that those swabs are meeting these same 

standards as the potential swabs when there is a choice between the two. And 

that is why we're actively engaged in a protocol to test multiple swabs and 

provide that data.

So we are highly motivated. We hear you and we are working towards that as 

a VA enterprise and beyond. As I said, not only are we here for VA and 

veterans, but as our fourth mission states we want to support the community 

and that's why the Office of Health will be open and we will be sharing data 

out through the MOU to make sure that it impacts the greater society.

Dr. Di Prima: And this is Matthew Di Prima from FDA. I want to provide some 

clarification. The MOU is not an alternative pathway. It's only for products 

that are legally marketed. Whether that's based off their base regulatory 

classification or from immediate effective guidance or EUAs. So this is totally 

optional and does not replace any FDA pre-market approach.

What it does, however, offer is the potential for a 3D printed swab to have a 

mark of clinical assessment through the MOU to address any concerns about 

the performance from diagnostic facilities or other hospitals.

(Ben Glendell-Ingler): Thank you.

Coordinator: Our next question comes from (John). Your line is now open.

(John): Hello. I was wondering what sterilization technique is recommended. I saw 
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hydrogen peroxide plasma technique was working for the swab.

Dr. Brenner: This is Sara from FDA. It was a little muffled. But I believe the question was 

about sterilization procedures. At this time, we don't have a recommendation 

on a specific sterilization procedure or anything like that. However, we're 

aware that sterilization is important. This is an important point of discussion 

in the community in determining what the best methods might be.

And we would encourage you again, to reach out to NIH, FDA and VA 

perhaps simultaneously to begin a conversation or jump into existing 

conversations on the most appropriate potential sterilization techniques as 

well as how to investigate the swabs once they've been sterilized, in other 

words, to evaluate what the effect of the sterilization process has been on the 

swab.

(John): Excellent. Thank you.

Coordinator: Our next question comes from (Mark Paxton). Your line is now open.

(Mark Paxton): Can I get a question in? I'm sorry. I was speaking with my mute on. Are you 

there?

Dr. Brenner: Yes. We're here.

(Mark Paxton): I'm so sorry. You hit the nail on the button a little bit here. My question is a 

follow-on question to the gentlemen that just preceded me was really about 

the standard for sterility assurance. You touched on it a little bit.

But is there a particular standard ISO, USP or any other standard that might be 
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out there that the agency is evaluating or requires? And I recognize that the 

device panels for both specimen collection kit bands for the non-sterile swabs 

are older device panels. So any insight that you have on that would be greatly 

appreciated. Over.

Dr. Brenner: Great. Thank you. Yes. We don't at this point have anything specific today 

with regards to a recommendation or what we would desire to see. You know, 

again, we're aware that there are a lot of different techniques being tried.

There are many different approaches that people have even started to publish 

on and produce data on. So we would like to be aware and informed as that 

information as it is coming forth.

And similar to the previous caller, I would encourage you to jump into that 

conversation that is active and ongoing, along with our colleagues at NIH and 

VA, so that we can collaboratively assess in real-time what the right paths 

might be.

(Mark Paxton): Very good. Thank you. I know this is perhaps beyond the scope of this call, 

but at least with respect to how these swabs are used in specimen collection 

kits, would that answer be the same for any of the transport media with 

respect to sterility assurance? Over.

Dr. Brenner: Yes. Another great question. And transport media is a topic that comes up a 

lot on our in vitro diagnostic town hall calls. I don't have a specific response 

to that in the case of 3D printed swabs other than to say we are aware that all 

of the steps from collection of specimen to analysis of the sample by whatever 

instrumentation or assay is used could impact the quality of the results.

So we need to be very careful to investigate media and anything else that is in 
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that pathway regardless of whether the swab is 3D printed or a traditional 

swab. So it's an important piece of the puzzle in this case just like the other 

puzzles.

(Mark Paxton): Yes, ma'am. Thank you.

Coordinator: Our next question comes from (Buren). Your line is now open.

(Buren): Hi, there. Thank you very much for the opportunity here. So I represent 

several contract manufacturers and I wanted to get an idea. There is talk that, 

you know, we do have a shortage of these swabs. But does anybody know 

exactly in terms of what kind of quantities we're looking for in the short kind 

of long-term?

The reason of why I ask about the short and long-term is usually 3D printing 

is very good for a short-term production run with the 300,000, 400,000, a 

million and so forth. But if you're thinking about the long-term in, you know, 

six months, a year and so on and so forth, we may be able to deploy other 

technologies like injection molding to essentially produce components that are 

very similar.

So I just kind of wanted to get an idea about, you know, any sort of quantity 

requirements that anybody would know about right now in the short-term and 

in the long-term as well and then sort of the way that we may be looking at 

injection molding as well as 3D printing as well.

Dr. Brenner: This is Sara from FDA. An excellent question. And that's certainly a hot topic 

in discussions that we've participated in beyond the agency. I can't give you a 

firm number of what's needed. That type of information in current projections 

are sort of held higher up in the federal government with task forces such as 
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the ones run from the White House and FEMA on national supply chain 

strategy.

So I won't venture, you know, to give any numbers that might be incorrect as 

of today. But you're absolutely right in pointing out the differences in capacity 

for short versus long run. And injection molding and other techniques are ones 

that have been brought to our attention.

So I would pause on that question for now and I would encourage you to

check-in or seek answers for those types of quantitative projection questions 

with sources like FEMA's task force on supply chain.

You can also shoot us an email and I could see if we could get an appropriate 

response for you that would not be attributed just to us and the experts on the 

phone today but across the federal government and what they're making 

publicly available on that.

I'd also like to ask if Matthew Di Prima has any comments or James Coburn,

since both are technical experts in alternative manufacturing methods, if they

have any additional comments on injection molding or the speed and capacity 

of production for these types of methods.

If you don't that's fine, but I wanted to pass it over in case you have a burning 

thought on the topic.

James Coburn: Hi. This is James. I'll just make one comment. I don't have a better number for 

the exact need and the time for that need. But one of the things that we have 

been looking at is not just the overall need for things like swabs, but the local 

need for those things as well with the transport issues or the shipping and 

movement issues from place to place.
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Sometimes having a local source especially in this time where people are 

locked down can be very useful. And it also makes it even harder to engage 

optimal capacity or optimal need for any given locality.

But just when you're thinking about that, you can take that into account as 

well. It's not just the bulk overall need for the country. It's where every 

locality might need that piece of medical equipment.

(Buren): Excellent. Okay. Thank you.

Coordinator: Our next question comes from Al. Your line is now open.

Al Siblani: Hi. This is Al Siblani. I'm the CEO for EnvisionTEC. We're a manufacturer of 

3D printing materials and we've been heavily involved with BIDMC to 

address the shortage of the NP swabs. Thank you all for taking the time today 

and primarily thanks to Sara who has been communicating with our staff on 

the NP swabs.

I have a couple questions. Just a little bit of background, you know, 

EnvisionTEC for the last 18 years have been delivering Class 1 devices. So 

this kind of falls in our lap and we're very comfortable in doing that.

Given what we have done so far where we have actually been granted testing 

on county-wide level, on city-wide level, like the City of New York where 

people are getting tested with our swab and as well we were even granted 

state-wide testing from some of the state governments.

My question is really kind of - it addresses the mechanical testing that you 

talked about. You mentioned tensile, flexional and torsional. And in our last 
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call with the FDA there was a mention that we should be getting some 

guidelines on that.

Do you have any type of timeline on this? Is this days or weeks? I mean, we 

are in a pandemic. There's a lot of need for these swabs and there is a 

significant shortage. And I want to add one thing which is very important 

before I pass it on to you is, you know, today our capacity is about 3 to 4 

million swabs a month and we're scaling up to go to 10 million a month.

So this can definitely be a very good way to build supplies in the cloud using 

3D printing. So can I get a sense of when those guidelines, specifically on the 

mechanical testing, will be provided to us.

Dr. Brenner: Yes. This is Sara from FDA. Thank you for everything that you're doing and 

everyone on the call is doing and on that question. We're very aware that folks 

are looking for this type of information. Unfortunately I can't give you an 

exact number of days today with regards to, you know, when that sort of 

information would come from FDA.

But what I can say is that in the conversation that has been ongoing here for 

the last hour and offline for many weeks now with our partners at NIH and 

VA, the community, which includes federal experts, has been putting together 

more specific information that folks, you and others, would want to take into 

consideration when you're performing different types of testing.

So the most immediate answer I can provide right now is to check back to the 

link that NIH is posting and the information that NIH will be providing on 

their site while we, the royal we, which includes FDA, continues to work on 

what we'll be able to communicate to the public.
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I would encourage you though to continue to reach back. So feel free to email 

me directly by the middle of next week if you don't feel like sufficient 

information has been provided and is acceptable to you. My email is 

Sara.Brenner@fda.hhs.gov.

Al Siblani: Great. Thank you for that. I appreciate it. Thank you all.

Coordinator: And that will be our last question for the presentation. I'd like to turn the call 

back over to Irene.

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

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

available on the CDRH webpage at www.fda.gov/training/cdrhlearn by 

Friday, May 22.

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 conclusion of today's town hall, please complete a short 13 

question survey about your FDA CDRH town hall experience. The survey can 

be found at www.fda.gov/cdrhwebinar immediately following the conclusion 

of today's live discussion. Again, thank you for participating. This concludes 

today's town hall.

Coordinator: That concludes today's conference. Thank you for participating. You may 

disconnect at this time. Speakers, please allow a moment of silence and stand 

by for your post-conference.
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END