Public Comment Started on FDA LDT Regulations

Pathologists and lab executives have 60 days to comment on draft guidance for regulating LDTs

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased in over 10 years. Per the draft guidance, no LDTs will be granted “grandfathered” status.

REGULATION OF LABORATORY-DEVELOPED TESTS (LDTs) is now one step closer to becoming reality. In recent weeks, the Food and Drug Administration took the actions required for it to begin regulating LDTs.

On September 30, the FDA posted two draft documents for LDTs on its website. Days later, on October 3, 2014, the FDA published notices of these two draft documents in the Federal Register.

The publication of the draft rules also started a 120-day period for public comment that will end on February 2, 2015. Pathologists, lab directors, and other interested parties have until that date to submit their comments to the FDA.

On its website, the FDA has provided documents with the draft guidance and information on how to submit comments about the draft guidance. (Use this link:

By moving forward with its intention to regulate LDTs, the FDA has stirred considerable controversy within the clinical laboratory testing industry. There are two sectors of the lab industry that will be affected by such regulation.

The first sector involves the overwhelming majority of clinical laboratories that daily perform LDTs that have been in use for decades. These tests have wide acceptance and there are few questions about their accuracy and clinical utility.

The second sector involves those laboratories—ranging from academic center labs and companies offering proprietary LDTs— that have developed a laboratory test and currently offer it to physicians and consumers under the existing LDT exemption.

In the first case, clinical labs offering LDTs that were developed years ago are concerned about having to meet burdensome regulations. In its draft rule, the FDA addresses this issue with a category of LDTs that it calls “low risk.”

In the second case, academic center labs, national reference and esoteric labs, and companies with proprietary tests have legitimate concerns about the time, cost, and clinical documentation that will be required by the FDA as part of its proposed process to assess and regulate LDTs that it defines as “moderate risk” or “high risk.”

Draft Guidance for Labs

In the draft guidance notices, FDA defined LDTs as “a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory” and that is intended for clinical use.

The framework for LDT regulation is found in the draft document titled, Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Oversight of Laboratory Developed Tests (LDTs).

The second draft document addresses guidance concerning notification. It is titled: Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs).

In the draft guidance, the FDA described how clinical laboratories will notify the agency about the LDTs they manufacture and how labs will use the FDA’s medical device reporting requirements.

Low, Medium, & High Risk

In an article for the website Lexology, lawyers for the law firm Jones Day explained that the FDA proposes applying its risk-based system for regulating medical devices to most LDTs based on whether they are low risk (Class I), moderate risk (Class II), or high risk (Class III).

Any LDTs that the FDA has previously cleared or approved will retain their existing device classifications, wrote Jones Day lawyers Laurie A. Clarke, Colleen M. Heisey, and Brigid C. DeCoursey. “However, FDA’s draft framework for regulating LDTs has effectively expanded the system by creating categories of LDTs that would be regulated first because they present the highest risk or be subject to minimal regulation to ensure availability or because they present the lowest level of risk,” they added.

The FDA will not immediately implement the entire draft framework. Instead, the FDA outlined multiple steps for applying these regulations. Additionally, the FDA stated that three categories of LDTs will be subject to minimal regulation. They are: LDTs for rare diseases, traditional LDTs, and LDTs for unmet needs.

As described in the draft guidelines, any laboratory that wanted to submit an LDT for approval would need to work through three steps of a five-step process. According to the Jones Day attorneys, in the first step toward approval, most laboratories would need to report adverse events associated with use of the LDT.

Descriptive Information

In the second step, clinical laboratories would need to submit descriptive information about their LDTs. In the third step, the FDA would classify each type of LDT based on any submitted adverse events and descriptive information. For this classification, the FDA will rely on comments from an advisory committee that the FDA will establish.

In the fourth step, the FDA will create priority lists for Class III and Class II devices based on their comparative levels of risk. And in a fifth and final step, clinical labs that have LDTs would be required to comply with the premarket and post- market requirements that FDA has specified for these devices, the Jones Day lawyers explained.

The FDA would begin regulating the highest-risk LDTs and then rate other LDTs based on the level of risk. After regulating the highest-risk LDTs, it would rate the other LDTs in Class III, then the LDTs in Class II, and then those in Class I, the lawyers wrote.

 Labs Must Notify FDA

Pathologists and lab administrators should be aware that their labs will need to notify the FDA about LDTs they manufacture. This will be true for both existing and new LDTs.

The FDA has proposed that laboratories identify and describe their LDTs within six months of publication of the final framework and guidance. To meet this requirement, laboratories must submit notification before the initial clinical use of any LDT introduced at least six months after publication of the final framework and when any LDT’s intended use is changed significantly.

In a notice to their clients, attorneys Jane Pine Wood and Rick Cooper of the law firm McDonald Hopkins explained that members of the clinical laboratory industry have contrasting views about the FDA’s plan to subject many LDTs to a new layer of regulatory requirements over the next 10 years. Some view the draft guidance documents as an essential step to improve patient safety. Others view regulation as a hindrance that will stifle diagnostic innovation and test improvement, they wrote.

FDA Determined to Act

“Despite that fundamental disagreement on the policy’s substance, there does seem to be consensus among informed observers that the FDA is determined to take action, that legislative intervention to block the agency faces long odds, and that the agency’s final guidance will create a regulatory challenge for labs unrivaled by anything out of Washington since CLIA ’88,” emphasized Cooper and Wood.

More Federal Regulation of Labs Is Unwelcome

ACROSS THE CLINICAL LAB INDUSTRY, there is opposition to the FDA’s stated intent to regulate laboratory-developed tests (LDTs).

This opposition was first voiced years ago, following statements by FDA officials that the agency intended to regulate LDTs. Several national laboratory associations have expressed their concerns about this new layer of government regulation over clinical laboratories. Among them are the Association for Molecular Pathology (AMP) and the American Clinical Laboratory Association (ACLA).

“We are deeply concerned by the FDA’s intent to add another layer of unnecessary regulatory oversight on laboratory-developed tests already subject to strict and thorough regulation,” said Alan Mertz, President of the ACLA. “Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law. There simply is no need for an additional layer of duplicative regulation that initiates more questions yet provides few answers.”

In a press release issued following the FDA’s notice to Congress on July 30 that it would regulate LDTs, AMP President Elaine Lyon, Ph.D., stated, “The CLIA program, in combination with laboratory accreditation programs and professional certification, provides the level of rigor, as well as the flexibility necessary, for ensuring high-quality laboratory testing in the U.S. Over-regulation or inappropriate regulation has the potential to negatively impact patient care and limit the availability of medically necessary laboratory developed procedures.”

These quotes illustrate why the clinical lab industry has concerns about the FDA’s plan to regulate LDTs. It would not be a surprise if some in the lab industry were to lobby Congress for regulatory relief on this issue..


American Congress of Obstetricians and Gynecologists Sends Letter to UnitedHealthcare about Its Concerns with BeaconLBS

JUST WEEKS BEFORE THE OCTOBER 1 IMPLEMENTATION of its laboratory benefit management pro- gram, officials at UnitedHealthcare (UHC) received a letter sent by the Florida District of the American Congress of Obstetricians and Gynecologists (ACOG).

On behalf of its member physicians, ACOG requested that “UHC suspend this test program as a requirement for Florida providers immediately and indefinitely.” The letter identified serious concerns that its members have about important aspects of the laboratory benefit management program and the BeaconLBS system that physicians are to use to obtain pre-notification or pre-authorization for certain medical laboratory tests.

ACOG’s members are concerned that use of the BeaconLBS system “may lead to prolonged patient waiting times and patient dissatisfaction,” along with other serious issues.

Based on our understanding, as of the implementation date of Sept. 1, 2014, Beacon LBS has failed in its efforts to interface with a very significant majority of eMRs/ eHRs currently in use. As a result, the implementation of the Beacon LBS, with its burdensome order entry process, will likely result in frequent and serious disruptions in office workflow.

…while an order entry process of this magnitude may seem acceptable to UHC and Beacon as a standalone item, when applied in a busy ambulatory setting, the process will likely be unmanageable or, at a minimum, very disrup- tive. These disruptions may lead to prolonged patient waiting times, patient dissatisfaction, critical order entry errors and possible underutilization of critical lab tests.

While there are other issues concerning the BeaconLBS program, those highlighted here compel us to request that UHC suspend this test program as a requirement for Florida providers immediately and indefinitely. UHC should be well aware of the ongoing interoperability challenges within the eMR/eHR industry and the ongoing efforts to correct the many problems. ACOG District XII values its relationship with UHC and recognizes our shared responsibility in improving the quality and efficiency of patient care. However, we view the implementation of the Beacon LBS program, in its current form, as a giant step backward.



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