Regulatory Open Forum

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Hello Ella,

I will leave some of the colleagues to comment on FDA. However, in Europe we have to report such incidents. Usually you will have sponsor and site assessment on the relationship of the death to the device. If it is not related you can assess it as not related, however you still need to notify the authorities of it. I guess it is similar with FDA but I will leave to the USA colleagues to confirm.

Have a great day,

Olga

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Ella,

If the device is not yet listed under the Medical Device Listing - does not matter whether marketed or not - you should consider reporting in the MAUDE database.  Typically a device adverse event during a clinical study would be reported as part of the clinical study as the device would not be marketed or listed.  However, if there is an existing cleared 510(k) and product is listed, then it would be assumed "on the market" regardless whether in normal use or clinical use.  A less regulatory risk would be reporting to MAUDE and reporting as part of the clinical study.  A higher regulatory risk would be only reporting as part of the clinical study.

Hello Ella,

I will leave some of the colleagues to comment on FDA. However, in Europe we have to report such incidents. Usually you will have sponsor and site assessment on the relationship of the death to the device. If it is not related you can assess it as not related, however you still need to notify the authorities of it. I guess it is similar with FDA but I will leave to the USA colleagues to confirm.

Have a great day,

Olga

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Thank you Richard!

This is very helpful!

What you wrote applies also if the death is non device related? I looked into CFR 803 and it looks that there is no requirement to report if this is the case.

The device is listed since last month.

Ella,

If the device is not yet listed under the Medical Device Listing - does not matter whether marketed or not - you should consider reporting in the MAUDE database.  Typically a device adverse event during a clinical study would be reported as part of the clinical study as the device would not be marketed or listed.  However, if there is an existing cleared 510(k) and product is listed, then it would be assumed "on the market" regardless whether in normal use or clinical use.  A less regulatory risk would be reporting to MAUDE and reporting as part of the clinical study.  A higher regulatory risk would be only reporting as part of the clinical study.

Hello Ella,

I will leave some of the colleagues to comment on FDA. However, in Europe we have to report such incidents. Usually you will have sponsor and site assessment on the relationship of the death to the device. If it is not related you can assess it as not related, however you still need to notify the authorities of it. I guess it is similar with FDA but I will leave to the USA colleagues to confirm.

Have a great day,

Olga

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Hi Ella,

Without seeing the full situation, awareness time, and such, could not really comment.  Typically when a serious injury or death occurs and Manufacturer becomes aware, then a report must be done.  Then investigation, review of event, follow-up, etc., are done and if the device had nothing to do with the report, then the Adverse Event report would be updated accordingly.  If the initial report of serious injury or death clearly showed the device has nothing to do with the event, then maybe a report is not made in the first place.  If the event was definitely not device related with the information provided by the reporter/physician/hospital, then most likely would not be reportable.

Thank you Richard!

This is very helpful!

What you wrote applies also if the death is non device related? I looked into CFR 803 and it looks that there is no requirement to report if this is the case.

The device is listed since last month.

Ella,

If the device is not yet listed under the Medical Device Listing - does not matter whether marketed or not - you should consider reporting in the MAUDE database.  Typically a device adverse event during a clinical study would be reported as part of the clinical study as the device would not be marketed or listed.  However, if there is an existing cleared 510(k) and product is listed, then it would be assumed "on the market" regardless whether in normal use or clinical use.  A less regulatory risk would be reporting to MAUDE and reporting as part of the clinical study.  A higher regulatory risk would be only reporting as part of the clinical study.

Hello Ella,

I will leave some of the colleagues to comment on FDA. However, in Europe we have to report such incidents. Usually you will have sponsor and site assessment on the relationship of the death to the device. If it is not related you can assess it as not related, however you still need to notify the authorities of it. I guess it is similar with FDA but I will leave to the USA colleagues to confirm.

Have a great day,

Olga

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Hello Ella,

I will leave some of the colleagues to comment on FDA. However, in Europe we have to report such incidents. Usually you will have sponsor and site assessment on the relationship of the death to the device. If it is not related you can assess it as not related, however you still need to notify the authorities of it. I guess it is similar with FDA but I will leave to the USA colleagues to confirm.

Have a great day,

Olga

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella

Dear Ella

For any serious adverse events (SAEs) in clinical studies - even if considered not device-related - I recommend to be transparent and report for the following reasons. 

Sometimes, incidences which were considered non-device related may later be device-related based on new information received.

Clinical studies published in high quality journals tend to report all incidents. In this case, they report the incident in the published study and the authorities/ authority representation then demand a report immediately or audit you on-site with out previous warning. A stressful situation for all. 

Please also consider the regulatory reporting requirements of the country in which the clinical study is being conducted. 

The above recommendations are to be considered non-country specific. 

Hi all

Just double checking myself with you :)

Class II medical device, cleared under 510(k) but not yet marketed in US. Death during clinical study but not device related.

No need to report MDR right? All the cinical study adverse event reporting was already performed.

Would appreciate also for solid justification for such decision.

Thank you

Ella