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Cleared medical device labeled as investigational

robert.beck

Involved In Discussions
#1
we have a 510(k) cleared class 2 device that is being in a drug study. the device is a monitoring device and is used to collect patient physiological response to medication administration. someone is telling me on some unknown authority that the devices must be labeled investigational. is there a regulatory or guidance document that requires this? where is this coming from.

the device is also CE marked and I'm getting the same requirement when it is used in a clinical trial in the EU, even though the device itself is not the subject of the trial. it is just a data collection tool.
 
#2
This doesn't sound right to me but I don't specialise in clinical investigations.

Are you using the device as intended by the instructions? Is it only indicated for some other drug? If so you are using it off label and this would have an impact
 

SKM.Sunil

Starting to get Involved
#3
we have a 510(k) cleared class 2 device that is being in a drug study. the device is a monitoring device and is used to collect patient physiological response to medication administration. someone is telling me on some unknown authority that the devices must be labeled investigational. is there a regulatory or guidance document that requires this? where is this coming from.

the device is also CE marked and I'm getting the same requirement when it is used in a clinical trial in the EU, even though the device itself is not the subject of the trial. it is just a data collection tool.

I am into clinical studies. I must say there is a requirement to label as an investigational device if the device is undergoing any clinical investigation (I am not talking about a clinical case collection/study). This clearly mentioned in ISO13485 & ISO14155, Please go through the guideline.
 
#4
I am into clinical studies. I must say there is a requirement to label as an investigational device if the device is undergoing any clinical investigation (I am not talking about a clinical case collection/study). This clearly mentioned in ISO13485 & ISO14155, Please go through the guideline.
It may be helpful if you give specific clauses in the standards (I can't see anything in 13485).

I can agree that this is required where the devices is undergoing investigation, however it sounds from OP that the device is being used as it is intended e.g a blood pressure monitor being used to monitor blood pressure during the study.
 

robert.beck

Involved In Discussions
#5
Yes, that's correct pkost. the device is being used according to its intended use to collect data. the device is not under investigation, but the data it collects supports one of the clinical study endpoints. The study is to evaluate a drug, so the drug is the thing under investigation. the device is being used as a data collection tool, much like a thermometer would be if body temperature had something to do with the drug's effect.

I can't find anything in ISO 13485:2003 or :2016. ISO 14155 is about conducting clinical trials, but focuses more on GCP (good clinical practice) than the use of measuring devices to collect data used to evaluate a study endpoint.
 

SKM.Sunil

Starting to get Involved
#6
Yes, that's correct pkost. the device is being used according to its intended use to collect data. the device is not under investigation, but the data it collects supports one of the clinical study endpoints. The study is to evaluate a drug, so the drug is the thing under investigation. the device is being used as a data collection tool, much like a thermometer would be if body temperature had something to do with the drug's effect.

I can't find anything in ISO 13485:2003 or :2016. ISO 14155 is about conducting clinical trials, but focuses more on GCP (good clinical practice) than the use of measuring devices to collect data used to evaluate a study endpoint.
ISO14155
5.10 Labelling
The investigational device, the instructions for use or the packaging shall indicate that the investigational
device is exclusively for use in a clinical investigation, if required by national regulations.

NOTE See ISO 15223-1[31, EN 1041[4] and national or regional regulations for further information on labelling.

I think as per the primary question Robert.Beck is collecting clinical data on his device, unless why he would be informed if someone else is in another trial using his device as a tool of measurement.
 

robert.beck

Involved In Discussions
#7
ISO14155
5.10 Labelling
The investigational device, the instructions for use or the packaging shall indicate that the investigational
device is exclusively for use in a clinical investigation, if required by national regulations.

NOTE See ISO 15223-1[31, EN 1041[4] and national or regional regulations for further information on labelling.

I think as per the primary question Robert.Beck is collecting clinical data on his device, unless why he would be informed if someone else is in another trial using his device as a tool of measurement.
I don't really understand this response. The device is NOT investigational because it has been assessed by a NB and has a CE Mark assigned to it. it also has 510(k) clearance in the US and is licensed in Canada. this device is not only being used in clinical trials; it is commercially available in the US and EU for sale outside of a clinical trial.

This looks to me like yet another overzealous application of a regulation due to poor understanding of nuances, and I think it is incorrect based on the section you cite. Please correct this if I'm wrong.
 

robert.beck

Involved In Discussions
#8
Just to re-emphasize the facts: the device is not exclusively for use in a clinical investigation. it has a Technical File which has been reviewed and approved by a Notified Body. it is a very effective device and thousands are sold every month for use by individual patients on a physician's order. these patients are not in a clinical trial. the device is sold and used as part of their treatment regimen by physicians.
 

SKM.Sunil

Starting to get Involved
#9
I don't really understand this response. The device is NOT investigational because it has been assessed by a NB and has a CE Mark assigned to it. it also has 510(k) clearance in the US and is licensed in Canada. this device is not only being used in clinical trials; it is commercially available in the US and EU for sale outside of a clinical trial.

This looks to me like yet another overzealous application of a regulation due to poor understanding of nuances, and I think it is incorrect based on the section you cite. Please correct this if I'm wrong.

Then you don't need to label your device as "Investigational" as far as you are not using it for clinical trials.
 
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