FDA Class II Medical Device Clinical Trials and and FDA IDE Requirements

invitro_spain

Involved In Discussions
#1
Hello all,

I have some doubts with regards to clinical studies and FDA IDE requirements. the Clinical Study is non-interventional and low-risk study and it is exempt to IDE requirements.

Is it mandatory to monitor this kind of Clinical study for a Class II device?
What about the data management? Could we manage the data in Excel?
The initial idea is to use a paper-based record in this case to assure the Data Integrity.
Do I need to follow the ICH-Good Clinical Practices?

Please, I need to clarify something about requirements and the best practices to do that.

:thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
the Clinical Study is non-interventional and low-risk study and it is exempt to IDE requirements.
Significant/Nonsignificant Risk

Is my study significant risk or nonsignificant risk?

FDA has a guidance document to help explain how to determine whether a device study is significant or nonsignificant risk. If the sponsor believes a device study is nonsignificant risk, the sponsor can provide information to the IRBs reviewing the study explaining why the device study does not pose a significant risk. If the IRBs agree and approve the study, the research may be conducted and FDA does not need to be notified. However, if an IRB determines the study is significant risk, the sponsor must notify FDA in writing (21 CFR 812.150(b)(9)). The study may not begin until FDA approves the study or provides a determination that the investigation is nonsignificant risk.
(https://www.fda.gov/MedicalDevices/...gationalDeviceExemptionIDE/ucm051480.htm#risk)

Have you gone through the above process and have a determination that the device study is nonsignificant risk?
 
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