How to determine when to label a medical device as investigational use only

Quality Assurance Specialist at Blackrock Microsystems

November 2018

< 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?

Marked as spam

Posted by Whitney Lewis

Asked on November 30, 2018 7:39 pm

2756 views

	Private answer Joe Hage Extremely timely question, Whitney. I could use that answer for a client right now! Marked as spam Report spam
	Private answer 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. Marked as spam Report spam
	Private answer 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. Marked as spam Report spam
	Private answer 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? Marked as spam Report spam
	Private answer 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! Marked as spam Report spam
	Private answer 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. Marked as spam Report spam
	Private answer Whitney Lewis Thank you, Annabella and Robert! Marked as spam Report spam

« Back to Previous Page

Meet your next client here. Join our medical devices group community.