Regulatory Open Forum

​Dear All,

Is there FDA guide that would clearly specify percentage of samples that have to pass the acceptance criteria in order for a parameter (in assay validation) to be considered 'validated' (for example, 75% of samples have to pass the acceptance criteria so a parameter is validated)?

Thank you,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

Konrad-

I'm not sure if you're referring to device or drugs. I'll answer for devices.
You would have to look at the ISO, ASTM, IEC etc standards that you are using to identify such acceptance criteria. There are howvere FDA guidance documents for specific classes of devices (drugs also I would assume) that list safety and performance requirements which would directly point to what standards you should be using. Here's the link :
https://www.fda.gov/RegulatoryInformation/Guidances/

Additionally, you can look up previous submissions (510(k)s if you are class 2 device manufacturer) on devices similar to yours from the FDA 510(k) database and identify what standards the industry generally complies with, this could save you time but is dependent on degree of novelty of your device which may encourage additional standardized testing.

Hope this helped.

------------------------------
Vidyalakshmi Jayaraman
Regulatory Affairs Specialist
Marlborough MA
United States
------------------------------

Original Message:
Sent: 05-Dec-2017 11:38
From: Konrad Kulak
Subject: assay validation - when a parameter is validated?

​Dear All,

Is there FDA guide that would clearly specify percentage of samples that have to pass the acceptance criteria in order for a parameter (in assay validation) to be considered 'validated' (for example, 75% of samples have to pass the acceptance criteria so a parameter is validated)?

Thank you,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

​Thank you very much Vidyalakshmi.
I will check the link you sent.
Thank you again,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

Original Message:
Sent: 05-Dec-2017 15:06
From: Vidyalakshmi Jayaraman
Subject: assay validation - when a parameter is validated?

Konrad-

I'm not sure if you're referring to device or drugs. I'll answer for devices.
You would have to look at the ISO, ASTM, IEC etc standards that you are using to identify such acceptance criteria. There are howvere FDA guidance documents for specific classes of devices (drugs also I would assume) that list safety and performance requirements which would directly point to what standards you should be using. Here's the link :
https://www.fda.gov/RegulatoryInformation/Guidances/

Additionally, you can look up previous submissions (510(k)s if you are class 2 device manufacturer) on devices similar to yours from the FDA 510(k) database and identify what standards the industry generally complies with, this could save you time but is dependent on degree of novelty of your device which may encourage additional standardized testing.

Hope this helped.

------------------------------
Vidyalakshmi Jayaraman
Regulatory Affairs Specialist
Marlborough MA
United States

Original Message:
Sent: 05-Dec-2017 11:38
From: Konrad Kulak
Subject: assay validation - when a parameter is validated?

​Dear All,

Is there FDA guide that would clearly specify percentage of samples that have to pass the acceptance criteria in order for a parameter (in assay validation) to be considered 'validated' (for example, 75% of samples have to pass the acceptance criteria so a parameter is validated)?

Thank you,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

Dear Konrad,

Please find below a link to the FDA guidance for industry Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. (ICH)
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073488.pdf 

Hope that you will find this useful! Have a nice day.

------------------------------
Nitisha Pyndiah PhD
Consultant
Hartmannwillner
Washington DC
United States
------------------------------

Original Message:
Sent: 05-Dec-2017 11:38
From: Konrad Kulak
Subject: assay validation - when a parameter is validated?

​Dear All,

Is there FDA guide that would clearly specify percentage of samples that have to pass the acceptance criteria in order for a parameter (in assay validation) to be considered 'validated' (for example, 75% of samples have to pass the acceptance criteria so a parameter is validated)?

Thank you,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

​Thank you very much Nitisha.
I noticed that FDA talks about establishing acceptance criteria and we establish them to be 15 or 20% of Relative Standard Deviation for most of the parameters but it is hard to find something at FDA guides that specifically states that if 70% pass the acceptance criteria a parameter is validated. So I guess we just have to justify to FDA why we think a parameter is validated based on a given sample size and given number of samples that passed the acceptance criteria?
Thank you again,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------

Original Message:
Sent: 06-Dec-2017 11:38
From: Nitisha Pyndiah
Subject: assay validation - when a parameter is validated?

Dear Konrad,

Please find below a link to the FDA guidance for industry Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. (ICH)
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073488.pdf

Hope that you will find this useful! Have a nice day.

------------------------------
Nitisha Pyndiah PhD
Consultant
Hartmannwillner
Washington DC
United States

Original Message:
Sent: 05-Dec-2017 11:38
From: Konrad Kulak
Subject: assay validation - when a parameter is validated?

​Dear All,

Is there FDA guide that would clearly specify percentage of samples that have to pass the acceptance criteria in order for a parameter (in assay validation) to be considered 'validated' (for example, 75% of samples have to pass the acceptance criteria so a parameter is validated)?

Thank you,
Konrad

------------------------------
Konrad Kulak
Biostat Solutions, Inc.
Frederick MD
United States
------------------------------