Hi Usha,
My understanding is that the device exemption is applicable if the clinical trial is about the device, which is not the case with you. From your explanation it seems it is a commercially available test that you want to use in a clinical trial.
I will leave some of the USA colleagues to comment on this but I can tell you that in Europe it is not required to submit anything additional for test used to evaluate safety of an experimental drug. If it is a commercially available test this is acceptable and you will likely not receive any comments about it. If it is a test designed for the study then you many need to provide them more information on validation, etc.
Have a great week,
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.ukUnited Kingdom
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Original Message:
Sent: 03-Jun-2023 16:09
From: Usha Srinivasan
Subject: Device exemption question
Hi Richard,
The clinical trial is for a medicinal product where pulse oximetry will be monitored for safety. The pulse ox device is approved for 21 yo and up and our study for the drug plans to include 18 yo and up. The advice the CRO gave us was for the sponsor to submit a device exemption with the FDA to be able include 18 yo and up for this specific study. Hope this gives a little more context.
I am looking to verify the accuracy of the advice as well as how to proceed with requesting an exemption, the lead time to get this 'approved" etc.
Thanks,
Usha
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Usha
Original Message:
Sent: 03-Jun-2023 10:43
From: Richard Vincins
Subject: Device exemption question
Usha,
Is the clinical trial original product a medical device or a medicinal product? So is it medical device + pulse oximeter or medicinal product + pulse oximeter?
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 02-Jun-2023 15:25
From: Usha Srinivasan
Subject: Device exemption question
We will be using a pulse oximetry device in one of our clinical trials. The device is approved for ages 21 and up. And we plan to include patients 18 and up in our study. I am told that we will need to "file an exemption" with the FDA to cover ages 18-21 for our study. Does anyone have experience with this type of a situation and shed some light on what/how we do next? Thanks in advance for any guidance you can provide.
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Usha
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