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Dear RAPS Community,
I'm looking for guidance from those of you that have experience with obtaining FDA clearance on IVD kits that include RUO/IUO reagents or LDTs. That said please forgive the lengthy thread, but I'm hopeful others have some good advice.
Background: My company has an IVD kit that incudes RUO reagents (a combination of off-the-shelf and custom reagents) that we source from several reagent manufactures and which we're hoping to eventually get FDA clearance for. The kit also requires use of RUO reagents that are required, but not provided. A similar version of the kit is already CE-marked as a Class I IVD in the EU. We intend on scheduling a pre-sub with FDA, but in the meantime are exploring multiple strategies. Ideally, we'd hold a pre-sub to inform FDA of the kit contents and get their approval on our plans to work with a clinical laboratory to validate the assay in their lab and which uses said RUO kitted reagents.
- Question 1: While eventually the reagents would need to be labeled for their intended use (upon clearance that is), can they remain labeled as RUO given the validation the lab would be doing is only analytical based and doesn't require clinical studies. I assuming they wouldn't need to be relabeled as IUO given no significant-risk studies are necessary and that regardless, the risk is low considering we'd be engaged in pre-sub discussions with FDA.
- Question 2: For those RUO reagents that are required, but not provided...would supplier agreements and controls be sufficient enough to show FDA that we have control over the supplier to prevent risk from changes that could potentially be made to the reagents. In other words, we contractual have them notify us of any changes to materials/processing/etc. for the RUO reagents that are required , but not provided.
- Question 3: Does anyone have experience with companies relabeling RUO reagents and kitting those reagents as part of their device as an IVD. If so, how would it be relabeled? What else needs to be considered exactly? This seems as though it would create all sorts of compliance risks and not suggesting it be pursued, but instead am interested in understanding the full ramifications.
As always, I look forward to hearing from fellow members and appreciate any insights provided.