Many diagnostic tests are commonly used for the clinical diagnosis of human diseases or conditions and in determining the state of health, such as cholesterol levels. These products are intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, tissue, urine, and saliva. Some test kits available in the market are designed for use by laypersons, like a home pregnancy test kit, while others are intended for use only by professionals in authorized laboratories.
FDA Regulation:
According to US FDA regulation 21 CFR 809.3, In Vitro Diagnostic (IVD) tests are considered devices and, like other medical devices, are subject to premarket and postmarket controls. They may also be regulated as biological products. Similar to medical devices, IVDs are classified into Class I, II, or III based on the level of regulatory control needed to reasonably assure safety and effectiveness. Before submitting an IVD, it is highly recommended to submit a Pre-Submission to obtain FDA feedback on the analytical and clinical studies plan prior to starting the studies.
IVDs are generally subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88), which establishes quality standards for laboratory testing and includes an accreditation program for clinical laboratories.
The complexity of the IVD testing methodology is categorized into one of three levels: waived test, moderate complexity, and high complexity. Manufacturers apply for CLIA '88 categorization during the IVD premarket process.
Laboratory developed test (LDT):
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured, and used within a single laboratory. LDTs are often the same as FDA-cleared or approved IVD tests, yet the FDA exercises enforcement discretion and generally does not enforce premarket review and other applicable FDA requirements on LDTs.
EU IVDR:
In Europe, the new In-Vitro Diagnostic Regulation (IVDR, (EU) 2017/746) is currently used to regulate IVDs. This regulation replaces the EU’s former IVD Directive (IVDD, 98/79/EC).
The IVDR includes major changes, such as moving from a classification method based on an all-inclusive list to a rule-based classification comprising four risk categories. The classification of the device is determined by its intended use and the analytes being measured.
This new classification may transform many IVDs, which were classified under the IVDD as General IVDs (and did not require the involvement of a notified body - self-declared), to a new classification that requires conformity assessment by a notified body.
The transition period for devices depends on the class of the IVD device under the IVDD and under the IVDR:
Devices placed on the EU market prior to 26 May 2022 as self-declared under the IVDD and that require the involvement of a notified body under the IVDR may be placed on the market or put into service under the IVDD until the following dates:
26 May 2026, for class D devices;
26 May 2027, for class C devices;
26 May 2028, for class B devices and class A devices placed on the market in sterile condition.
Devices placed on the EU market prior to 26 May 2022 under the IVDD with notified body certificate, may be placed on the market or put into service under the IVDD until 26 May 2025.
IVD devices developed by health institutions must be CE marked in compliance with IVDR. However, no CE mark is required if the IVD is manufactured and used only within the same health institution, with the precondition that there is no equivalent device available on the market that can meet the target patient group's specific needs.
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