Regulatory Open Forum

How do you handle IDE devices that are part of a recall?  They are not commercially sold in the US.  Are they handled like any other recall and submission of an 806 report is required?  Please help.

Hello Anon,

You are correct in the statement IDE (significant risk or non-significant risk) devices are not commercially sold in the United States, so therefore they are not submission to the provisions under 21 CFR 806 or 21 CFR 7.  However, they are subject to the provisions under 21 CFR 812 and Good Clinical Practices (GCP) meaning any products needing to be taken out of use or corrected in the field would fall under the clinical investigations parameters.  If there is an existing approved IDE (for significant risk devices) this would require reporting to US FDA and IRB which then for IDE Exempt (for non-significant risk devices) would require reporting to IRB.  It all depends on why an investigation device is being taken out of use or being "recalled" because if there is a safety concern this has significantly different implications than maybe if some product was not labelled properly as part of the clinical investigation.  It also depend on if the recall of product from the investigation is due to adverse device effect or unanticipated adverse device effect which has different implications as well.  Full traceability and accountability of devices is needed in a clinical investigation.

How do you handle IDE devices that are part of a recall?  They are not commercially sold in the US.  Are they handled like any other recall and submission of an 806 report is required?  Please help.

Thank you Richard.  It is being recalled because of a safety concern.  The products have all been accounted for.

Hello Anon,

You are correct in the statement IDE (significant risk or non-significant risk) devices are not commercially sold in the United States, so therefore they are not submission to the provisions under 21 CFR 806 or 21 CFR 7.  However, they are subject to the provisions under 21 CFR 812 and Good Clinical Practices (GCP) meaning any products needing to be taken out of use or corrected in the field would fall under the clinical investigations parameters.  If there is an existing approved IDE (for significant risk devices) this would require reporting to US FDA and IRB which then for IDE Exempt (for non-significant risk devices) would require reporting to IRB.  It all depends on why an investigation device is being taken out of use or being "recalled" because if there is a safety concern this has significantly different implications than maybe if some product was not labelled properly as part of the clinical investigation.  It also depend on if the recall of product from the investigation is due to adverse device effect or unanticipated adverse device effect which has different implications as well.  Full traceability and accountability of devices is needed in a clinical investigation.

How do you handle IDE devices that are part of a recall?  They are not commercially sold in the US.  Are they handled like any other recall and submission of an 806 report is required?  Please help.

I agree with Richard. I worked QARA for IDE studies at the VA. Traceability is important as well as continuous contact with subjects. We had a subject with an implanted IDE Retire from the USA in Mexico and stop communications with us. We held a meeting with the IRB and the FDA was there. After a long discussion, FDA allowed us to use the subject's Facebook posts with him fishing in the ocean as evidence he is not harmed.

Thank you Richard.  It is being recalled because of a safety concern.  The products have all been accounted for.

Hello Anon,

You are correct in the statement IDE (significant risk or non-significant risk) devices are not commercially sold in the United States, so therefore they are not submission to the provisions under 21 CFR 806 or 21 CFR 7.  However, they are subject to the provisions under 21 CFR 812 and Good Clinical Practices (GCP) meaning any products needing to be taken out of use or corrected in the field would fall under the clinical investigations parameters.  If there is an existing approved IDE (for significant risk devices) this would require reporting to US FDA and IRB which then for IDE Exempt (for non-significant risk devices) would require reporting to IRB.  It all depends on why an investigation device is being taken out of use or being "recalled" because if there is a safety concern this has significantly different implications than maybe if some product was not labelled properly as part of the clinical investigation.  It also depend on if the recall of product from the investigation is due to adverse device effect or unanticipated adverse device effect which has different implications as well.  Full traceability and accountability of devices is needed in a clinical investigation.

How do you handle IDE devices that are part of a recall?  They are not commercially sold in the US.  Are they handled like any other recall and submission of an 806 report is required?  Please help.