LDT: Legal Distinction Terminated

Monday, June 21, 2010

Within the span of a couple weeks, a number of big things have happened around FDA's Office of In Vitro Diagnostics (OIVD). Chief among these:

  • FDA posted "untitled" letters it sent to the leading direct-to-consumer genomics firms and a key instrument vendor. These letters state FDA's opinion that the tests and services in question are medical devices subject to regulation. 

  • FDA commissioner Margaret Hamburg and NIH director Francis Collins co-wrote an opinion piece in the New England Journal of Medicine about the regulation of personalized medicine. The editorial stated that regulatory agencies intend to "help make personalized medicine a reality" by making "substantial investments in infrastructure and standards" to produce "better outcomes" for patients.

  • FDA announced they are holding two days of public meetings to discuss the level of enforcement that will be shown toward Laboratory-Developed Tests (LDTs). The announcement was pretty blunt: "FDA believes that a risk-based application of oversigh to LDTs is the appropriate approach." 

  • CDRH director Jeffrey Schuren publicly acknowledged that FDA is finally pulling the plug on IVDMIA. 

Taken separately, any one of these events is significant. Indeed, every one of them generated brief articles in several industry publications. These are not unrelated announcements, however. Instead, these announcements are a window through which we can see that a different reality has already taken hold at OIVD.

The new reality is that OIVD no longer sees much advantage to observing a significant distinction between IVDs and LDTs.

Industry asked for consistency on LDTs and now it looks like we're going to get it: Most products that currently enjoy "enforcement discretion" will lose that status in the foreseeable future. Can't get much more consistent than that.

FDA has announced that it is "seeking input" on this change. Let's be clear, though... this change in enforcement is a done deal and your suggestions to the contrary won't amount to a pile of 23andMe test results.

The only meaningful questions left to ask now are who's next and whether it's possible to come up with a regulatory plan before it's your turn.

How can I be so sure? Because I've watched this change in thinking take hold gradually as I've attended numerous pre-IDE meetings and reviewed untitled letters that didn't get published on FDA's web site. I've privately suspected that the trend was going this direction for a while, but even in public, FDA has broadly hinted at big changes. Most of what is significant about last week's news is that it no longer requires special knowledge to see which way the wind is blowing. They've laid it all out for us.

Last week's "untitled" letters were the opening salvo of the public campaign, but they weren't news to most of the recipients. What happened last week was a spectacle staged for public consumption... a bit like the recap on a TV show in case you missed the last episode. They have now served that purpose and the next round of letters will be a great deal less courteous.

FDA understands that suppliers are the Achilles Heel of the LDT industry. LDT makers can argue all they want about whether they should be allowed to do what they do... but if they can't buy an instrument or reagent, they've got big problems. Modern medical testing is too complex to do without the help of sophisticated partners and that type of partner will have too much riding on their investments to risk being drawn into this mess.

As the Illumina letter illustrated, they are also going after the CLIA labs' key partners, such as instrument and reagent suppliers. Illumina's letter wasn't the first or only untitled letter we've seen regarding provision of RUO products to labs doing diagnostic testing. It certainly won't be the last. FDA could have sent that letter to dozens of companies, but they only needed to publicize one in order to put all suppliers on notice.

Without having to flex even one new muscle, FDA will effectively isolate LDT marketers from the industry mainstream. The rest of industry will ultimately have to choose between maintaining their LDT sales or their reputations.

FDA is keeping this deliberately low-key right now, but they couldn't possibly be more clear about what they intend to do. Anyone who plans to market a test related to human health beyond the next couple years should be sitting up and paying very careful attention to what is happening now. Enforcement may not come to your neck of the woods for a few years, but it may take years for you to do the work required for compliance.


Tags: Design Control, Enforcement, FDA, FDA 101, IVDMIA, LDTs, QSR, Warning Letters

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Glossary Terms

Center for Devices and Radiological Health (CDRH)
Clinical Laboratory Improvement Act (CLIA)
In Vitro Diagnostic (IVD)
In Vitro Diagnostic Multivariate Index Assay (IVDMIA)
Investigational Device Exemption (IDE)
Laboratory Developed Test (LDT)
Office of In Vitro Diagnostic Devices (OIVD)
Research Use Only (RUO)