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Whitney Lewis
Quality Assurance Specialist at Blackrock Microsystems
November 2018
How to determine when to label a medical device as investigational use only
< 1 min reading time

Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?

The devices are not cleared and some may or may not be on a path to be cleared, and the studies being done are not to prove the safety or effectiveness of the device but to aid in research only, but on humans.

Does this labeling requirement only apply when the device itself is under evaluation? or always when using a un-cleared device in human testing?

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Posted by Whitney Lewis
Asked on November 30, 2018 7:39 pm
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Joe Hage

Extremely timely question, Whitney. I could use that answer for a client right now!

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Annabella Jucius

I believe the investigational use only label requirement is for the device being evaluated only but I suggest asking your FDA reviewer for input.

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Robert Packard

If the device is currently labeled for research use only, the device will need to be relabeled for investigational use only. If the device is for a significant risk study, then IDE approval will be required and the proposed labeling is included in the IDE submission.
If the device is currently cleared, but you intend to use the device of a different indication in a clinical study, you will still need to relabel the product for investigational use only.
If the study is a non-significant risk study, then you will still need to relabel product for investigational use, but only the IRB must approve of the proposed labeling.

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Whitney Lewis

Annabella, I understand it that way as well, though I am not sure who the FDA reviewer would be since we are not sponsoring the studies. Any Thoughts?

Robert, I agree with everything you stated, as that is what is in the regulation. However, it is still unclear to me whether or not this applies to studies the manufacturer is not sponsoring. On that note, are there regulations (outside of IVD devices) that guide manufacturers on Research Use Only labeling, or is this terminology specific to IVD products; and other medical devices are either cleared or not and if it is a research product it is not a medical device?

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Annabella Jucius

I would solicit further guidance from the regulator reviewing the research application (e.g., FDA, EMA, JFDA, etc). If you're not sponsoring the study, the individual/entity who is, can request the information. Alternatively, I suggest contacting a regulatory affairs consultant with experience in IVD devices for additional insight. Good luck!

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Robert Packard

It is not clear from your description what the relationship is between the sponsor and the manufacturer. If a sponsor initiates a study without your assistance, then you can't revise the labeling for the study. However, if the sponsor is engaging you, then you should be relabeling the product for investigational use. In addition, you will want to make sure you are being notified of any adverse events or complaints so that your company can process them and report AEs to the FDA.

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Whitney Lewis

Thank you, Annabella and Robert!

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