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- FDA’s Newest Proposal Regarding Laboratory Developed Tests (LDTs) Once Again a Gross Overreach
FDA’s Newest Proposal Regarding Laboratory Developed Tests (LDTs) Once Again a Gross Overreach
November 17, 2023
Laboratories: Submit Your Comments by December 4th
On September 29, 2023, the Federal Drug Administration (FDA) introduced a proposed rule regarding laboratory-developed tests (LDTs). According to the FDA, this rule would end the FDA’s current “enforcement discretion” policy for LDTs. LDTs would therefore be regulated by the FDA “under the same enforcement approach” as In Vitro Diagnostics (IVDs) and subject to regulatory requirements as medical devices.
The Proposed Rule includes a phased implementation approach over the four years following the rule’s effective date, with LDT “manufacturers” (i.e., the laboratory) required to comply with regulatory requirements in stages, as shown in the table below. The FDA has attempted to regulate LDTs many times before over the years, thus far unsuccessfully. The FDA suggests that it has the authority to regulate LDTs as devices.
At XiFin, we see this Proposed Rule as a gross overreach by the FDA, encroaching into space that is already well-regulated by the Clinical Laboratory Improvement Amendments (CLIA)
Lâle White
CEO and Executive Chairman, XiFin
LDTs are NOT devices and therefore the FDA does not have authority regarding LDTs under current law. As a matter of fact, physicians practicing medicine utilize reagents and machines using their technical expertise and clinical judgment to develop and validate tests subject to oversight under CLIA. The FDA is not charged with regulating learned experts. Acknowledging this authority question, Congress has considered—and rejected—legislation giving the FDA authority over LDTs. At XiFin, we see this Proposed Rule as a gross overreach by the FDA, encroaching into space that is already well-regulated by the Clinical Laboratory Improvement Amendments (CLIA). Our position is that The Federal Food, Drug, and Cosmetic Act (FD&C Act) does not give the FDA authority to regulate LDTs.
We believe this FDA encroachment on the regulatory authority over LDTs will further diminish the ability of labs to practice medicine. In fact, during the COVID-19 pandemic, the FDA’s guidance document for even expedited emergency oversight led to decreased availability of testing, particularly in the early stages of the pandemic, and contributed to the catastrophic course the pandemic took in the US. The Proposed Rule has significant potential implications for laboratories. First and foremost is the cost of compliance. Second is the cost to patients if laboratories are no longer able to provide access to valuable LDTs due to the cost of complying with the Proposed Rule. In other words, the Proposed Rule incorporates no consideration of LDT benefits. The FDA acknowledges that this Proposed Rule could lead to the removal of some LDTs from the market.
In short, the Proposed Rule is bad for patients and bad for laboratories.
LDTs provide a critical pathway for innovation and patient access. Requiring FDA review of LDTs will create bureaucratic bottlenecks and cost barriers to this innovation, exponentially increasing the cost and time to market for vital diagnostics. Notably, the Proposed Rule doesn’t include “grandfathering” provisions for LDTs already on the market. This will cause a flood of applications and the FDA lacks the resources to handle the thousands of submissions that will be filed. This will create a massive backlog and dramatically slow down access to existing and new LDTs.
Patients will suffer from both tests no longer being available and tests whose availability is delayed. The current LDT pathway strengthens our national healthcare system by enabling rapid response to emergent threats. Required FDA regulation of LDTs will reduce the resiliency of the American healthcare system.
Our Voices Matter
While anticipated judicial challenges to the FDA’s oversight of LDTs could significantly delay the publication and effective date of the final rule, we believe it’s vitally important for laboratories to submit comments before midnight December 4th, 2023, supported by specific evidence of the value of LDTs. Creating a robust record of the challenges created by the Proposed Rule for patients and the diagnostics industry–through the comment process–is one of the best ways for laboratories and advocates to paint the full picture of the impact of the Proposed Rule.
YEAR 1
One year following the effective date of the rule, laboratories offering LDTs will be responsible for adhering to the Medical Device Reporting (MDR) and correction and removal reporting requirements.
YEAR 2
Two years after the effective date of the rule, LDTs will need to adhere to FDA requirements related to registration, listing, labeling, and investigational device exemptions. This includes registering with the FDA as a “device” manufacturer and listing all LDTs performed.
YEAR 3
Three years after the effective date of the rule, laboratories offering LDTs will be required to comply with the Quality System Regulation (QSR) (including good manufacturing practices applicable to medical devices).
YEAR 3.5
Three and a half years after the effective date of the rule (no earlier than October 1, 2027), “high-risk” (i.e., Class III) LDTs will be subjected to full Pre-Market Approval requirements under the Federal Food, Drug, and Cosmetic Act. This includes applying for pre-market approval (PMA) to the FDA.
YEAR 4
Four years after the effective date of the rule (no earlier than April 1, 2028), “moderate” (i.e., Class II) and applicable “low-risk” (i.e., Class I) LDTs will be required to fulfill the full 510(k) premarket notification and de novo requirements under the FDCA, unless eligible for an exemption.
The Proposed Rule indicates that the FDA doesn’t plan to enforce actions against LDTs for which 510(k)s and de novo applications are submitted within this four-year period until the FDA review is complete.