Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

This message was posted by a user wishing to remain anonymous

You could contact the FDA's animal and veterinary branch, known as the Center for Veterinary Medicine (CVM). They may be able to provide helpful information.
Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

DEAR ANONYMOUS:

We came across this below PDF Guidance - please check 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-655100-devices-use-animals 

It says among other things below:
"

BACKGROUND:

There are many articles falling under the definition of a device in Section 201(h) of the FD&C Act which are intended for animal use which are parallel in intent and function to devices intended for human use. There are, however, a number of articles which are peculiar to animal use and have no parallel human use. Devices intended for animal use require no pre-marketing clearance. They may, however, be deemed to be adulterated or misbranded under the general provisions of 501 and 502 as may be determined by the *Center for* Veterinary Medicine.

"
So the question that goes begging--does you medical device intended for animal use have parallel use in humans?

Let us know if you need more help- and if youc an share more information/details per above statement, happy to consult our SmartSearch Plus+ to drill down further on your behalf.

See https://tinyurl.com/2aa4uus5 

Regards,
Ram Balani
eSTARHelper LLC

------------------------------
Ram Balani
CEO
FDASmart Inc. /eSTARHelper LLC www.estarhelper.com
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 04-Jan-2023 20:28
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

You could contact the FDA's animal and veterinary branch, known as the Center for Veterinary Medicine (CVM). They may be able to provide helpful information.
Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

This message was posted by a user wishing to remain anonymous

I tried.  I was on the phone for over 30 minutes.  I will look for an email.  Thanks!
Original Message:
Sent: 04-Jan-2023 20:28
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

You could contact the FDA's animal and veterinary branch, known as the Center for Veterinary Medicine (CVM). They may be able to provide helpful information.
Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

This message was posted by a user wishing to remain anonymous

You can email CVM at AskCVM@fda.hhs.gov
Original Message:
Sent: 05-Jan-2023 17:36
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

I tried.  I was on the phone for over 30 minutes.  I will look for an email.  Thanks!
Original Message:
Sent: 04-Jan-2023 20:28
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

You could contact the FDA's animal and veterinary branch, known as the Center for Veterinary Medicine (CVM). They may be able to provide helpful information.
Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

Hello Anon

There are various rules depending on what kind of device or diagnostic it is...

Basic labeling rules apply to most all of them.
https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates

There are additional rules if the product involves lasers, x-rays, MRI, etc.
https://www.fda.gov/animal-veterinary/animal-health-literacy/how-fda-regulates-animal-devices

Electrical devices are subject to electrical safety requirements.
https://www.osha.gov/nationally-recognized-testing-laboratory-program/frequently-asked-questions

If the diagnostic device is a biologic test kit, USDA is quite interested,
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/CT_Vb_pel_faqs

And so on. If there's a specific area you're looking at, we might be able to point you to more specifically relevant guidance.

Here's an interesting perspective on how some of the various relevant agencies formally and informally handle overlapping areas in their regulatory purviews.
https://www.nfwf.org/sites/default/files/bats/Documents/decision_support_tool.pdf

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!

This message was posted by a user wishing to remain anonymous

Thank you everyone,

This was really useful information.  It is nice to have a place to start.
Kind regards,

Original Message:
Sent: 04-Jan-2023 14:58
From: Anonymous Member
Subject: Animal medical device

This message was posted by a user wishing to remain anonymous

Hello community,

I would like to know what resources can I look at to help me understand and comply to regulations on animal medical devices/ diagnostic testing.  I looked at both FDA and USDA and I became confused?  I understand that I do not need to submit an application to the FDA for an animal medical device.  However, it is not making sense to me if there are specific standards or regulations that I need or must follow for either organization.

Please advise.  Thanks!