Hello Michelle,
It does not matter if the sample results are reported back to the patients, for IVD products if samples are taken from a patient, then it would be considered a clinical investigation. With that said, there are some other methods can be utilised for IVD samples such as de-identified samples or leftover samples that could be used without performing a full clinical investigation. The IVD world is a little different with clinical investigations, but if taking patient samples for any reason on non-approved/non-cleared devices, should still need a study in place.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Mar-2020 16:02
From: Jeffrey Freedman
Subject: Patient Samples
The samples are being used to determine the safety and/or effectiveness of the device, so they are clinical samples and you are performing a clinical investigation.
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Jeffrey Freedman
Regulatory Affairs Specialist II
Lowell MA
United States
Original Message:
Sent: 05-Mar-2020 07:46
From: Michelle Hughes
Subject: Patient Samples
Hi Everyone,
I am currently working on a project involving a device that will analyze patient urine samples. My question to the group is if the device validation testing utilizes patient urine would that be considered a clinical investigation per 21 CFR 812.3 (h)? Would your response change if the specimens were certified drug free urine samples? The results of the tests will not be reported to the patient.
Thank you.
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Michelle Hughes
Senior Regulatory Affairs Consultant
Jacksonville FL
United States
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