"Mere placement of an RUO or IUO label on an IVD product does not render the device exempt from otherwise applicable clearance, approval, or other requirements. FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed."
—Final RUO Guidance
The newly finalized RUO Guidance is out and the obvious first question is what has changed? A lot has changed about the structure and tone, but it appears that very little about the underlying motivations. FDA appears ready to get serious about RUO.
The first thing that jumps out about the final guidance is the stronger tone. Instead of being conversational and speaking about what the manufacturer knows, it focuses in on what the manufacturer does. This shift is reflected even in the title, which addresses "Distribution" of IVDs, rather than "Commercially Distributed" IVDs. They appear ready to hit the reset button on what you think you're allowed to do based on years of precedent.
Digging in a bit, contrast this bit from the draft:
"If the manufacturer of an IVD product labeled RUO were to assist in the validation or verification of the performance of a test that the manufacturer knows is used in clinical diagnosis using its RUO-labeled IVD product, FDA would consider such assistance to be evidence of non-research intended use. As explained above, this may render the device misbranded..."
With a correponding section of the final:
"FDA views the activities of a manufacturer that aid the clinical laboratory in validation or verification of a test that incorporates RUO or IUO labeled IVD products as evidence of the manufacturer’s intended use. If the manufacturer of an IVD product labeled RUO or IUO were to assist in the validation or verification of the performance of a test for clinical diagnostic use that uses its RUO or IUO labeled IVD, that assistance would be considered to be evidence of a non-research or non-investigational intended use."
FDA took some hits for making state of mind a subject for regulatory enforcement in the draft. You won't see that in the final guidance anywhere now. Instead, the onus is shifted to the manufacturer and FDA retains the ability to make final determiniations. In a paragraph so crucial they printed it twice, FDA indicates:
"When determining whether non-compliance with statutory and regulatory requirements warrant a regulatory and/or enforcement action, FDA intends to consider the totality of the circumstances concerning a manufacturer’s sale and distribution of a product labeled as RUO or IUO."
And for those who regularly sell into CLIA labs, the following point should be sobering:
"[A] manufacturer who produces only products labeled RUO whose sales force makes routine calls to clinical laboratories that do not perform research or clinical studies may be viewed as demonstrating its intent that its products be used for clinical purposes."
No doubt we'll have more to say about this guidance and how it relates to the landmark NGS clearances from earlier this week. Stay tuned!