PLEASE NOTE: This page describes a guidance that no longer reflects FDA's current thinking. It is here for historical reference only.
What is IVDMIA?
IVDMIA has been a draft guidance for long enough that many in industry have begun to act as though it may not come to pass. While there is no official announcement yet, there are strong suggestions that this rule may have cleared its biggest hurdle and is likely to become enforceable in the foreseeable future.
IVDMIA, in a nutshell, expands the scope of ordinary IVD regulations. It has been the case for years that many lab-developed tests (LDTs) were exempt from IVD regulation if the companies who developed them set up CLIA labs and only sold results. With IVDMIA, FDA promises to significantly narrow this exception to IVD regulations. Many LDTs that could previously be marketed under CLIA will face additional regulatory scrutiny if they wish to remain on the market long term.
How we can help
Myraqa has extensive expertise with the IVD clearance and approval process that will soon govern such tests. If your business faces new challenges in the wake of IVDMIA, we can help identify them, assess your risks and help create a plan for complying with the new regulatory requirements. Myraqa is involved with several companies developing IVDMIA products and has had the opportunity to talk directly with FDA about these new requirements. AMDM recently paired up our CEO with a key FDA reviewer for an expert panel discussion of IVDMIA.
Myraqa can perform a preliminary risk assessment to determine what gaps exist in your IVDMIA preparedness. Should significant risk exist, MyRAQA can help develop a compliance strategy and assist you through all phases of the regulatory process.
Competitive opportunity
Nobody likes additional regulation and for many LDTs, IVDMIA represents a significant new burden.
From a competitive postion, however, there is a silver lining to be found in this cloud. You are not the only company that faces this situation -- your competitors face it too. Those companies who clear this hurdle earliest will likely find themselves at a significant competitive advantage.
There is still time to be proactive, but your competition is beginning this process too.
Don't miss the opportunity to call us before they do.
