FDA New Product Introduction Regulations help needed

E

Eunseok

#1
I am Sean of iNtRON biotechnology.
Intended use of our product is :
1) Diagnosis of disease of human and animal. I have more interest in the case of animal.
2) Possibly research us only in the lab


Our company is planning to launch our products at US market and before launching, I would like to be sure about the regulations of FDA.


1. I would like to know if FDA has separate regulations for human being and animal to use of IVD or ASR’s.


2. I would like to know if FDA has a special guideline for “research use only” of IVD or ASR’s.


3. I would like to know that our company’s products are in what category among IVD, ASR’s and GPR.


4. If I want to sell our products without any intention of diagnostic use (research use only), do I still have to be regulated by FDA?


5. If I want to sell our products with the intention of diagnostic use, what process do I have to follow to meet the regulation of FDA?


I attached the product list of iNtRON’s products.

Basically, our products are based on the PCR and detect a certain DNA with electrophoresis.(DNA or RNA extraction -- Amplification by PCR -- Detect the certain DNA/RNA)

The product category can roughly divide by two, For Human and for animal.

Please see the description of the attached. You can see the kinds of gene or virus.

If you want to send email, please send to intosean at intronbio.com
 

Attachments

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bio_subbu

Super Moderator
#2
Hi

Welcome to the cove!!

I would suggest you to refer the USFDA Guidance document on “Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions”.

The aforesaid guidance document can be accessed from here.

Regards
S. Subramaniam
 
V

Vincnet

#3
Hi Eunseok

1. I would like to know if FDA has separate regulations for human being and animal[/COLOR] to use of IVD or ASR’s.

As far as I know there is not regulation for animals IVDs so far.


2. I would like to know if FDA has a special guideline for “research use only” of IVD or ASR’s.

Yes and it ASR's have been a pretty hot subject at FDa for a few years now especially in you field (molecular diagnostics)

3. I would like to know that our company’s products are in what category among IVD, ASR’s and GPR.

Well as this one needs some thinking it a consultant's job

4. If I want to sell our products without any intention of diagnostic use (research use only), do I still have to be regulated by FDA?

no but they can decide to pull your ear at some point if their attention is raised on the fact that your products are use in a non RUO setting. More over this will highly restrict your communication on your products in the USA

5. If I want to sell our products with the intention of diagnostic use, what process do I have to follow to meet the regulation of FDA?

Same as for 3)
This is a set of quick answers with a limited view of your products and your intents so nothing is cast in the stone there, final answers could be very different. You should visit FDA's IVD website some, answers are there hidden :) and/or request help from a consultant (which I happen to be :D )

Hope this helps

V
 
Y

yana prus

#4
Dear Sean:
1. I would like to know if FDA has separate regulations for human being and animal to use of IVD or ASR’s.
IVD:
Yes, FDA has separate regulations for human being and animal to the use of IVD. Please refer to "How FDA regulates veterinary devices" http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047117.htm
Pre-market Approval is Not Required: The FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. Device manufacturers who exclusively manufacture, or distribute veterinary devices are not required to register their establishments and list veterinary devices.
FDA recommends that devices should meet or be equivalent to the performance standards. This is especially important devices that can be used both in humans and animals.
It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.
FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure that it complies with labeling and regulations. This includes devices marketed in another country and offered for importation into the U.S.
3. I would like to know that our company’s products are in what category among IVD, ASR’s and GPR.
Generally speaking, you can check the classification of IVD here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm
the search will provide you with the product code, submission type and special guidances to follow (if any).
4. If I want to sell our products without any intention of diagnostic use (research use only), do I still have to be regulated by FDA?
For regulatory framework for IVD products for research use only, please refer to page 41 of IVD Device studies - Frequently Asked Questions guidance from June 25, 2010:
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm071230.pdf
there is no need in registration and listing, no need to submit pre-market application, it is exempt from QSR requirements, the labeling shall bear the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures."
5. If I want to sell our products with the intention of diagnostic use, what process do I have to follow to meet the regulation of FDA?
on the same page of the above mentioned guidance you can find the requirements for regulatory framework for IVD products.

Good Luck!

Yana Prus
 
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