Diagnostic laboratories in today’s world face a slew of issues; from managing complicated test panels to handling ever-increasing sample quantities. In order to overcome such problems, busy laboratories discover new methods to expand. They make themselves flexible, necessary enough, to keep up with the proliferation of pathogens. Knowing the regulatory environment is crucial for the efficient development and implementation of any diagnostic test whether it be an IVD or an LDT.
How do you know if your assay is an IVD or LDT?
In-Vitro Diagnostics (IVDs) by definition, are diagnostic instruments used either alone or in combination, for the in vitro examination of specimens derived from the human body. These products are developed by IVD manufacturers, often gathered in a box referred to as a test kit, and may be utilized in laboratories, health care facilities, or even at home. On the other hand, many laboratories develop their own testing methodology, called Laboratory Developed Tests (LDTs), and execute good validation of them within their laboratory, as LDTs play a significant role in the provision of high-quality health care. An LDT by definition, is an in vitro diagnostic test that is created, produced, and used exclusively inside the confines of a single laboratory. As a result of this core difference between the IVDs and the LDTs, the regulatory framework that is applicable to both of these assays also differs, especially in terms of the required regulatory submissions, clearances, and optional or mandatory compliance requirements.
What goes along with IVD regulatory submissions?
IVD manufacturers must submit a substantial quantity of documents to the regulatory authorities in order for their kits to be approved. These documents should include information on how the performance of the device affects patient health, specifically the effects of false negative and positive results. A manufacturer must label an IVD product in compliance with labeling laws before obtaining marketing clearance or approval. Prior to approval, all technical documents, including clinical and analytical performance data, must be provided to the regulatory authority to demonstrate the device’s safety and efficacy. Although regulatory authorities typically seek data from clinical samples with adequate laboratory and/or clinical characteristics to allow an assessment of a novel device’s clinical validity, they seldom demand prospective clinical trials for IVDs.
What clearances are mandatory for an LDT?
A laboratory must have adequate conditions, following the Clinical Laboratory Improvement Amendments (CLIA) program, in order to set up an LDT. CLIA aims to provide a precise and reliable diagnosis. Before revealing any test results, laboratories are required to get CLIA certification, and the Center for Medicare and Medicaid Services (CMS) will audit them to make sure they are in compliance. Since the test will solely be utilized in a laboratory setting, all analytical validations are only conducted there. Validation done elsewhere is therefore neither essential nor relevant.
Over the last two decades, the regulatory bodies have proposed various draft guidances and documents on LDT regulations. Although LDTs are considered medical devices, they do not require regulatory clearance or approval prior to use. IVDs that aren’t LDTs must adhere to all medical device rules in the jurisdiction in which they’re sold legally. The regulatory authorities will interact with the laboratory via a warning letter identifying regulatory violations if an IVD is being sold erroneously as an LDT.
No manufacturer would wish to have a regulatory body question them on their misconceptions about IVDs and LDTs. We at Elexes, have an excellent team of experts to help you understand what category your assay would fall into and help you with the appropriate regulatory pathway. Feel free to write to firstname.lastname@example.org to know more about IVDs and LDTs.
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Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.