Regulatory Open Forum

Hello RAPS colleagues,

Questions regarding IRB disagreement of sponsor's NSR determination of an IVD.

In the case of multiple sites where one IRB disagrees with sponsor's NSR determination, can sponsor continue to enroll patients in other sites which were active while waiting to receive FDA's determination? Or should the sponsor stop enrollment at all sites while waiting to receive FDA's determination? What happens to patients who are on treatment at those other sites? 

The regulations under 21 CFR 812.66 states that if an IRB determines that an investigation involves a significant risk device, the IRB will notify the investigator and, where appropriate, the sponsor. The sponsor must notify FDA within 5 days under 21 CFR 812.150. Sponsor may not begin the investigation unless FDA action occurs under 21 CFR 812.30. 

I interpreted the above regulations to apply to the entire study, not site-specific; therefore, the study must stop while awaiting FDA feedback. I believe this is a potential risk when approaching each IRB as opposed to seeking FDA determination up front. I would like to confirm the accuracy of (or correction of) my interpretation.  

Thanks for any insights or experience anyone can share. 

Hello,

We had something similar with a client in the past and they put the study on hold until they had the FDA decision.

Good luck with your study.

Olga

Hello RAPS colleagues,

Questions regarding IRB disagreement of sponsor's NSR determination of an IVD.

In the case of multiple sites where one IRB disagrees with sponsor's NSR determination, can sponsor continue to enroll patients in other sites which were active while waiting to receive FDA's determination? Or should the sponsor stop enrollment at all sites while waiting to receive FDA's determination? What happens to patients who are on treatment at those other sites? 

The regulations under 21 CFR 812.66 states that if an IRB determines that an investigation involves a significant risk device, the IRB will notify the investigator and, where appropriate, the sponsor. The sponsor must notify FDA within 5 days under 21 CFR 812.150. Sponsor may not begin the investigation unless FDA action occurs under 21 CFR 812.30. 

I interpreted the above regulations to apply to the entire study, not site-specific; therefore, the study must stop while awaiting FDA feedback. I believe this is a potential risk when approaching each IRB as opposed to seeking FDA determination up front. I would like to confirm the accuracy of (or correction of) my interpretation.  

Thanks for any insights or experience anyone can share. 

Hello RAPS colleagues,

Questions regarding IRB disagreement of sponsor's NSR determination of an IVD.

In the case of multiple sites where one IRB disagrees with sponsor's NSR determination, can sponsor continue to enroll patients in other sites which were active while waiting to receive FDA's determination? Or should the sponsor stop enrollment at all sites while waiting to receive FDA's determination? What happens to patients who are on treatment at those other sites? 

The regulations under 21 CFR 812.66 states that if an IRB determines that an investigation involves a significant risk device, the IRB will notify the investigator and, where appropriate, the sponsor. The sponsor must notify FDA within 5 days under 21 CFR 812.150. Sponsor may not begin the investigation unless FDA action occurs under 21 CFR 812.30. 

I interpreted the above regulations to apply to the entire study, not site-specific; therefore, the study must stop while awaiting FDA feedback. I believe this is a potential risk when approaching each IRB as opposed to seeking FDA determination up front. I would like to confirm the accuracy of (or correction of) my interpretation.  

Thanks for any insights or experience anyone can share.