In Vitro Diagnostic devices (IVD) play a pivotal role in healthcare by aiding in the diagnosis of conditions and informing treatment strategies. In the United States, these devices are regulated according to their risk level and categorized into one of three classes, each requiring a different type of premarket submission.
Laboratory Developed Tests (LDTs), which are IVDs crafted, manufactured, and utilized within a single clinical laboratory, have historically been subject to a level of enforcement discretion by the FDA, sparing them from the premarket submissions mandated for other IVD categories. However, a significant shift occurred in September 2023 when the FDA proposed a rule aiming to eliminate this enforcement discretion.
The new rule mandates that LDTs undergo the same premarket application processes as other In Vitro Diagnostic devices, categorized by risk level. This transition is planned to unfold over four years through a five-stage phased approach, requiring manufacturers to submit premarket applications (PMAs) for high-risk LDTs within 3.5 years of the final rule’s publication, and 510(k) premarket notifications within four years.
Major Reclassification of High-Risk In Vitro Diagnostic Devices to Moderate-Risk to Simplify Regulatory Processes
Adding to the evolving regulatory landscape, on January 31, 2024, the FDA announced its intention to reclassify most high-risk (Class III) IVDs as moderate-risk (Class II) devices. This reclassification primarily affects IVDs used in diagnosing and managing infectious diseases and companion In Vitro Diagnostic devices. The agency anticipates utilizing the de novo classification request for initial In Vitro Diagnostic devices, streamlining the premarket submission process compared to the PMA pathway. Specific In Vitro Diagnostic devices highlighted in this announcement include those assisting in the diagnosis and/or management of Hepatitis B Virus (HBV), Human Parvovirus B19, and Mycobacterium tuberculosis.
This move is part of a broader FDA strategy to recalibrate the classification of certain IVDs, as evidenced by recent reclassifications of specific Hepatitis C and Human Immunodeficiency Virus (HIV) IVDs from Class III to Class II. The criteria for determining which IVDs remain in Class III versus those transitioning to Class II are not explicitly defined by the FDA, aside from an assessment of whether special controls would suffice in ensuring safety and efficacy.
Navigating Changes for Faster, Safer Device Approval
The implications of these regulatory adjustments are significant for manufacturers and stakeholders in the IVD sector. Emergo by UL predicts that the FDA will endeavor to reclassify as many eligible IVDs as possible within the next two to three years. This timeline aligns with the proposed schedule for LDT regulatory submissions and aims to reduce the number of LDTs necessitating PMA submissions. This strategy underscores the FDA’s commitment to maintaining device safety and effectiveness while avoiding unnecessary regulatory hurdles that could delay market entry.
For companies navigating these changes, particularly those with devices transitioning from Class III to Class II, the regulatory pathway may involve using a previously approved PMA device as a predicate for a 510(k) submission. However, the absence of published special controls for a specific device type could introduce uncertainty regarding the requisite testing to meet FDA standards.
Emergo by UL recommends engaging in a Pre-submission (Pre-sub) consultation with the FDA to clarify testing requirements and expectations for novel or reclassified device types. This proactive approach can facilitate alignment with the FDA and streamline the regulatory process for IVD manufacturers aiming to introduce or continue offering their devices in the U.S. market.
Resource: Emergobyul, February 12, 2024
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