Invitro refers to tests conducted outside of a living organism while maintaining comparable physiological conditions.
In vitro diagnostic medical devices encompass reagents, instruments, and systems utilized for diagnosing diseases, assessing health, facilitating treatment, preventing illness, and collecting, preparing, and examining specimens from human samples to evaluate disease prognosis and overall health status.
The FDA Clinical Laboratory Improvement Amendments (CLIA) categorizes in vitro diagnostics (IVDs) according to their technical complexity, the expertise required by users, the stability of materials, and the operational processes involved Reagents, System, Instruments.
IVD aids in diagnosis, predicts risk, monitors, and identifies effective populations for which a drug is beneficial, thereby assessing the risk of various diseases or conditions.
The testing method includes the use of technology like PCR, mass spectrometry, and immunoassay, the type of specimen (serum, plasma, venous whole blood, etc.), the nature of the results (quantitative, qualitative, etc.), patient demographics (symptomatic or non-symptomatic), and populations at elevated risk (intensive care units).
The usage context of a specific IVDs is within a laboratory setting, at point-of-care locations like emergency departments or medical clinics, for individual home use.
In vitro diagnostic (IVD) reagents are classified into three classes based on their risk level: Class I (General Controls, exempt from premarket review) for 50% of IVDs, Class II (General Controls & Special Controls, FDA 510k exempt, 45% of IVDS), and Class III (PMA, ~5% of IVDs). Class I reserved devices require premarket review through a 510(k).
Parts of the Code of Federal Regulations (CFR) Pertaining to In Vitro Diagnostics (IVDs) are :
21 CFR 809: labelling requirements, definitions, confidentiality etc.,
21 CFR 812: regulatory requirements for studies, including some exemptions for certain IVD.
21 CFR 820: Quality System Regulation for IVDs.
21 CFR 862: IVDs devices in the Chemistry panel
21 CFR 864: IVDs devices in HEMATOLOGY AND PATHOLOGY panel which include GPRs and ASRs.
21 CFR 866: IVDs in immunology and microbiology panels.
Factors influencing IVD reagent quality include raw materials, process development, performance assessment methods, internal reference products, and clinical evaluation. Raw materials and manufacturing processes must meet quality requirements and validated thoroughly.
The evaluation of in vitro diagnostic (IVD) reagents is based on their analytical performance, which includes precision, accuracy, sensitivity, specificity, and linear range, and their clinical performance, which relies on human specimens.
The 510(k)-approval process, by the U.S. Food and Drug Administration (FDA) is serves as a pathway for manufacturers to introduce new medical devices into the market.
In the case of in vitro diagnostics (IVDs) just like ither medical devices, this process requires the demonstration of substantial equivalence to an existing legally marketed predicate device.
This entails providing evidence that the new IVD is comparably safe and effective as the predicate device, sharing similar intended uses and technological features.
Conclusion
The FDA 510k Submission process is crucial for introducing new medical devices into the U.S. market, especially in vitro diagnostic (IVD) devices. The quality of IVD medical devices depends on raw materials and manufacturing processes, and evaluation focuses on analytical and clinical performance metrics.
The FDA ensures the safety and effectiveness of these devices, and manufacturers must prepare thoroughly for the submission process, which mandates accurate and precise IVD medical devices.
Ms. Suman Mishra (M.Pharm)
Regulatory Consultant — FDA 510k Medical Devices