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FDA Gives Up on Final Guidance for Laboratory Developed Tests (LDTs)

Monday, November 28, 2016   (0 Comments)
Posted by: Stephen Rapundalo
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FDA had signaled late last week that it has abandoned its efforts to finalize the draft guidances for LDTs. The agency received a mix of approval and criticism in response to those drafts. However, the recent election results and current political landscape, essentially scuttled proceeding forward on a final guidance. It’s unclear when the FDA’s efforts to issue far-reaching LDT guidance will pick up again…it could be quite a while, given how long it took to develop the draft guidances.

 

The absence of any guidance does not mean FDA will ignore labs or abandon their major concerns with LDTs. It’s likely that FDA will take enforcement action against LDTs by indirect approaches. For instance, the agency may turn its attention back to the marketing of Research Use (RUOs) and Investigational Use (IUOs) devices utilized in LDTs. The FDA may well attempt to narrow exempt LDTs by expanding the scope of tests deemed to be direct-to-consumer (DTC)., though DTCs remain undefined. Or the agency could try to assert greater oversight of test processes by requiring pre-market clearance or approval for collection devices for specific intended uses. Another approach would be for the FDA to issue “safety” communications that declare perceived risks with a specific test or group of tests, and the resulting publicity would diminish the use of the implicated test(s). Lastly, FDA could challenge laboratory tests as not qualifying as LDTs.

 

Thus, the future for the regulation of LDTs is unclear. MichBio will continue to monitor this issue and engage in the appropriate policy discussions as they emerge. So stay tuned!


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