Regulatory Open Forum

Dear All,

I would like to see if anyone knows whether FDA requires IRB approval for IVD clinical studies using only unidentifiable leftover clinical samples.

The clinical study will form part of a 510(k) submission and will be conducted outside of the US. In the study, only commercially available leftover biospecimens (e.g. blood, nasal swabs) taken from US patients will be used. The data collected will be used to evaluate the sensitivity and specificity of the IVD product.

According to the NIH's Research Involving Private Information or Biospecimens Flowchart, our study is not classified as human subject research thus IRB approval is not required. However, from the FDA guidance Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, it states that only informed consent is waived and there is no mention as to whether IRB approval is required. It is uncertain whether an IRB approval is required based on the information we found.

Any comments or experience sharing are appreciated!

Many thanks,
Veronica

------------------------------
Veronica Wong
Regulatory Affairs Manager
Hong Kong
------------------------------

Section IVg of this guidance states that IRB review is required in this case.

------------------------------
Cynthia Phillips
VP Regulatory and Clinical Affairs
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 12-Aug-2020 05:03
From: Veronica Wong
Subject: FDA IRB requirement for IVD studies using unidentifiable leftover biospecimens

Dear All,

I would like to see if anyone knows whether FDA requires IRB approval for IVD clinical studies using only unidentifiable leftover clinical samples.

The clinical study will form part of a 510(k) submission and will be conducted outside of the US. In the study, only commercially available leftover biospecimens (e.g. blood, nasal swabs) taken from US patients will be used. The data collected will be used to evaluate the sensitivity and specificity of the IVD product.

According to the NIH's Research Involving Private Information or Biospecimens Flowchart, our study is not classified as human subject research thus IRB approval is not required. However, from the FDA guidance Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, it states that only informed consent is waived and there is no mention as to whether IRB approval is required. It is uncertain whether an IRB approval is required based on the information we found.

Any comments or experience sharing are appreciated!

Many thanks,
Veronica

------------------------------
Veronica Wong
Regulatory Affairs Manager
Hong Kong
------------------------------

Dear Cynthia,

Thank you very much for the advice.

Many thanks,
Veronica

------------------------------
Veronica Wong
Assistant Regulatory Affairs Manager
New Territories
Hong Kong
------------------------------

Original Message:
Sent: 13-Aug-2020 17:43
From: Cynthia Phillips
Subject: FDA IRB requirement for IVD studies using unidentifiable leftover biospecimens

Section IVg of this guidance states that IRB review is required in this case.

------------------------------
Cynthia Phillips
VP Regulatory and Clinical Affairs
Salt Lake City UT
United States

Original Message:
Sent: 12-Aug-2020 05:03
From: Veronica Wong
Subject: FDA IRB requirement for IVD studies using unidentifiable leftover biospecimens

Dear All,

I would like to see if anyone knows whether FDA requires IRB approval for IVD clinical studies using only unidentifiable leftover clinical samples.

The clinical study will form part of a 510(k) submission and will be conducted outside of the US. In the study, only commercially available leftover biospecimens (e.g. blood, nasal swabs) taken from US patients will be used. The data collected will be used to evaluate the sensitivity and specificity of the IVD product.

According to the NIH's Research Involving Private Information or Biospecimens Flowchart, our study is not classified as human subject research thus IRB approval is not required. However, from the FDA guidance Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, it states that only informed consent is waived and there is no mention as to whether IRB approval is required. It is uncertain whether an IRB approval is required based on the information we found.

Any comments or experience sharing are appreciated!

Many thanks,
Veronica

------------------------------
Veronica Wong
Regulatory Affairs Manager
Hong Kong
------------------------------