Siddhartha230
Registered
Hello,
We have an optical coherence tomography (OCT) device for skin cancer (the predicate "may" be "K153283_ VivoSight Dx Topical OCT System"),
and we want to conduct some tests in the USA to know if there are some specifications we have to modify.
I have consulted the 21 CFR PART 812.2(c)(4), and I think that if our test will...
1. only for the consumer preference,
2. not for the purpose of determining the safety or the effectiveness, and
3. does not put the subjects at risk,
our test will not subject to 21 CFR PART 812 (IDE), right?
But, is there any regulation or guidance do we have to follow? (I only know some research use only (RUO) products guidances for IVD, not for the medical device.)
Do we just declare that our tests will meet the three rule in 21 CFR PART 812.2(c)(4), and no need to submit the declaration to any administration sector?
Do we need to apply for the IRB permission?
The final question is if we declare that our tests are only for the consumer preference, and does not put the subject at risk, the results of the tests can not be used as an evidence for the safety and effectiveness, right?
Thank for your help very much.
Lucas
We have an optical coherence tomography (OCT) device for skin cancer (the predicate "may" be "K153283_ VivoSight Dx Topical OCT System"),
and we want to conduct some tests in the USA to know if there are some specifications we have to modify.
I have consulted the 21 CFR PART 812.2(c)(4), and I think that if our test will...
1. only for the consumer preference,
2. not for the purpose of determining the safety or the effectiveness, and
3. does not put the subjects at risk,
our test will not subject to 21 CFR PART 812 (IDE), right?
But, is there any regulation or guidance do we have to follow? (I only know some research use only (RUO) products guidances for IVD, not for the medical device.)
Do we just declare that our tests will meet the three rule in 21 CFR PART 812.2(c)(4), and no need to submit the declaration to any administration sector?
Do we need to apply for the IRB permission?
The final question is if we declare that our tests are only for the consumer preference, and does not put the subject at risk, the results of the tests can not be used as an evidence for the safety and effectiveness, right?
Thank for your help very much.
Lucas
