Analyte Specific Reagents (FDA requirements) for combination Antibodies

[invitro_spain]

My company is a Monoclonal antibodies manufacturer and we are thinking to export our products to the US market as Analyte Specific Reagents (ASR). My company is located in Spain.

I have reviewed “Commercially Distributed Analyte Specific Reagents (ASRs): Frecuently Asked Questions” but I still have many doubts about this guidance:

Can anybody tell me what steps we should follow to sell our products in USA?

What kinds of restrictions the ASRs have?

Can we only mark as ASRs single antibodies? What about the combinations?

Thank you in advance

 

[Stijloor]

Help anyone?

Thank you.

Stijloor.

 

[Marc]

Another "Bump" in case someone here can help. My Thanks in advance!

 

[Statistical Steven]

Let me ask around today with some colleagues. Should not be too difficult.

 

[Statistical Steven]

If you are ONLY distributing ASR (not making any claims of use with a test), it is exempt from premarket notification requirements under section 510(l) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 360(l).

Combining more than one ASR would require regulatory approval similar to any other IVD.

Refer to this for more information on the expectations of the agency.

This guidance document refers to three regulations as "the ASR rule." Published in 1997, the regulations define and classify ASRs (21 CFR 864.4020), impose restrictions on the sale, distribution, and use of ASRs (21 CFR 809.30), and establish requirements for ASR labeling (21 CFR 809.10(e)).

Assume you are a class I unless it meets the risk requirement of Question 5 of the guidance document.

The advice I was given is if you are unsure have a meeting with the FDA OIVD or CBER.

Hope that helps!

 

[invitro_spain]

My company is a Monoclonal antibodies manufacturer and we are thinking to export our products to the US market as Analyte Specific Reagents (ASR). My company is located in Spain.

I have reviewed “Commercially Distributed Analyte Specific Reagents (ASRs): Frecuently Asked Questions” but I still have many doubts about this guidance:

Can anybody tell me what steps we should follow to sell our products in USA?

What kinds of restrictions the ASRs have?

Can we only mark as ASRs single antibodies? What about the combinations?

Thank you in advance

Thank you very much for this useful information.
We will try with single antibodies not combinations regarding to ASR rules. Yes, I am quite sure that these antibodies are Class I.

In this case, Must we only do the company and the product list registration in FDA Database? First, We must prove that we comply with 21 CFR 820, I think. We meet ISO 13485:2003 Quality System even I know there are differences between these regulations.

Can anyone some experience in FDA registrations?

 

[Ajit Basrur]

Thank you very much for this useful information.
We will try with single antibodies not combinations regarding to ASR rules. Yes, I am quite sure that these antibodies are Class I.

In this case, Must we only do the company and the product list registration in FDA Database? First, We must prove that we comply with 21 CFR 820, I think. We meet ISO 13485:2003 Quality System even I know there are differences between these regulations.

Can anyone some experience in FDA registrations?

For the ASRs, these links would be useful to you.

Frequently Asked Questions

Product Classification

21 CFR Part 864.4020

 

[Marc]

Thanks, Steve and Ajit!