FDA Further Explains Delay on LDT Guidance

Regulatory NewsRegulatory News | 13 January 2017 |  By 

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

As FDA explains, “LDTs play an increasingly important role in the provision of high-quality health care and many laboratories perform good validation of their LDTs and provide high-quality, professional management of their operations. However, currently, patients and providers cannot uniformly rely on all tests offered for clinical use as some are not subject to active premarket oversight to ensure they provide accurate measurements and valid claims.”

Several praised the move to delay the final guidance, particularly as a new administration and Congress work with FDA and the Centers for Medicare & Medicaid Services (CMS) to come up with a new way of regulating LDTs.

Rachel Sachs, a law professor at Washington University in St. Louis, told Focus: “I have been very impressed with the collaborative spirit demonstrated by the FDA and CMS under the leadership of Commissioners [Rob] Califf and [Andy] Slavitt. The discussion in this paper of FDA/CMS collaboration is just one of many recent examples of collaboration between the agencies in ways that have potential to make the process of innovation and regulation more predictable and efficient.”

But the move by FDA also could be a sign of what’s to come from an agency that could see defections if the deregulation promises from the incoming administration hold up.

Jacob Sherkow, a professor at New York Law School, told Focus: “I think, with the new administration, there's going to be a lot of defection from FDA, even with lower-level career positions. I have gotten the impression that, since November, FDA has released a lot of guidances and recommendations because (a) career staff want to wrap up loose ends before they leave; and (b) it's an effort to lock FDA into certain positions concerning safety and efficacy that might be upended by whoever heads the agency next month.

“Here, I think since the FDA largely committed to its deference approach for LDTs in its previously announced guidance, whoever's on that job is trying to move the ball forward, ever so slightly, in the hope that inertia will further that policy. I guess the idea is that without further statement, a new Commissioner would be ever more inclined to simply announce a lack of any oversight whatsoever, despite the rank and file objection,” he added.


In addition to a synthesis of feedback received on the proposal put forth in 2014, “with the hope that it advances public discussion on future LDT oversight,” FDA also points to several alternatives to what was proposed and should be considered, including:

  • Exempting LDTs already on the market from all FDA oversight except for adverse event and malfunction reporting (“grandfathering”), and exempting traditional LDTs and LDTs for public health surveillance from all oversight;
  • Not adopting proposals requesting laboratories to notify FDA of their LDTs on the market because FDA generally would no longer need to classify LDTs currently on the market as the result of “grandfathering”;
  • Providing additional time before FDA would begin actively overseeing certain regulatory requirements; and
  • Shortening the overall phased-in timeframe.

Sachs also told Focus: “I'm disappointed in the decision to grandfather in essentially all existing tests, especially after the FDA's efforts to demonstrate the existence of patient harm due to several of these LDTs. With that said, the paper does encourage even those tests to be subject to adverse event reporting, which may provide the FDA with more evidence going forward as it seeks to regulate these technologies.”

A phased-in timeline from FDA also was laid out in the paper:

  • “Year One: Serious adverse event and malfunction reporting for all LDTs except: traditional LDTs, LDTs intended solely for public health surveillance, certain stem cell/tissue/organ transplantation LDTs, and LDTs intended solely for forensic use.
  • Year Two: Premarket review for new/modified LDTs with the same intended use as an IVD approved under a PMA (i.e., tests that have already been identified as high risk by FDA).
  • Year Three: Premarket review for new/modified LDTs with the same intended use as a Class II device type subject to 510(k) clearance (i.e., tests that have already been identified as moderate risk by FDA).
  • Year Four: Premarket review for new/modified LDTs that do not fall into the above categories.”

Discussion Paper on Laboratory Developed Tests (LDTs)


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