Regulatory Open Forum

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.
 
The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


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SheilaAustinRegulatory Specialist
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Hi Sheila,

It seems that your inventor should be able to file his own EUA. The wording "not currently marketed in the US" should cover this -as his "new" device is not currently marketed. The wording currently doesn't explicitly require the device be marketed anywhere else either.

So, from a regulatory standpoint, you should be good to move forward with an EUA under the recent guidance. As for potential intellectual property issues, which could exist with respect to the current manufacturer, I will let someone smarter than I am about these things tackle them.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 06-Apr-2020 13:56
From: Sheila Austin
Subject: Ventilator EUA

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.

The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


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SheilaAustinRegulatory Specialist
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Hi Sheila ,
Here attached the Template of the Ventilator  EUA, which you can use to submit 
let me know if you need any help
Thanks

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YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
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Original Message:
Sent: 06-Apr-2020 13:56
From: Sheila Austin
Subject: Ventilator EUA

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.

The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


------------------------------
SheilaAustinRegulatory Specialist
------------------------------

My instincts are that it probably doesn't matter, because my best guess is that every ventilator that will be used in the current pandemic is already at a healthcare facility, in the distribution channel, or being manufactured.  Nothing that hasn't already been authorized for emergency use is likely to be used, and that the overwhelming majority of the devices that have already been authorized for emergency use will never be produced in any quantity.

It also seems unlikely that the pandemic will create a significantly expanded market for ventilators going forward, including DIYs.  At best, you might hope to catch the next pandemic, but if the next one creates an unusually high demand for ventilators, some work will probably have been done on supply chain and distribution issues that the current pandemic has shined a spotlight on, and that there will be an adequate supply Next Time.

It seems that the supply of ventilators is most likely increasing at a brisk pace, while the overall demand is about to start slacking off, and that those two lines will intersect within a matter of a few weeks, if they haven't already.

I say all this even though it is outside the bounds of regulatory and you didn't ask, because, if your inventor is holding off on requesting EUA until he has some assurance his device will get it, he is most likely seeing this as a potential business opportunity.  I'm doubtful that it is one, and also inclined to think it is becoming less of one with each passing day.  Whether this information proves useful to you, it may be a perspective that others in this forum will want to consider.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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Original Message:
Sent: 06-Apr-2020 13:56
From: Sheila Austin
Subject: Ventilator EUA

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.

The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


------------------------------
SheilaAustinRegulatory Specialist
------------------------------

FDA held a public conference call for industry yesterday that covered this topic. The recording will be available at CDRH Learn. See the "Specialty Topics" updated 4/06/2020. The presentation has information but just as importantly includes a contact designated as a Rapid Response for issues like this.

https://www.fda.gov/training-and-continuing-education/cdrh-learn

See also the EUA page here.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 06-Apr-2020 13:56
From: Sheila Austin
Subject: Ventilator EUA

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.

The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


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SheilaAustinRegulatory Specialist
------------------------------

Thanks to all of you for weighing in on this.  I will review the webinar.  I also do think your comments are spot on Julie.​
Sheila Austin

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SheilaAustinRegulatory Specialist
------------------------------

Original Message:
Sent: 07-Apr-2020 11:21
From: Andrea Chamblee
Subject: Ventilator EUA

FDA held a public conference call for industry yesterday that covered this topic. The recording will be available at CDRH Learn. See the "Specialty Topics" updated 4/06/2020. The presentation has information but just as importantly includes a contact designated as a Rapid Response for issues like this.

https://www.fda.gov/training-and-continuing-education/cdrh-learn

See also the EUA page here.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States

Original Message:
Sent: 06-Apr-2020 13:56
From: Sheila Austin
Subject: Ventilator EUA

​Hello,

I am a Regulatory Specialist at an academic institution.  A faculty/inventor holds a patent that was licensed to a Ventilator Manufacturer for a ventilator that received 501k clearance (product code CBK)  and was in use for a period of time.  The manufacturer has since marketed several generations of updated ventilator devices.

The faculty/inventor has updated his original design and would like to submit an EUA independent of the Ventilator Manufacturer of the previous product to the FDA.  He proposes a build in house with off the shelf components.

What is your opinion of the this scenario meeting the criteria for an EUA submission - "The ventilators, ventilator tubing connectors, and ventilator accessories that are eligible for inclusion under this EUA are those that are not currently marketed in the U.S.; or that are currently marketed in the U.S but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket 510k to FDA as set forth in the FDA's Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance."

Your advice is much appreciated.
Sheila Austin


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SheilaAustinRegulatory Specialist
------------------------------