What are IVDs?

Per 21 CFR 809.3, FDA defines in vitro diagnostic (IVD) products as those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.  IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.

Similar to medical devices, FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process. The Code of Federal Regulations lists the classification of existing IVDs in 21 CFR 862, 21 CFR 864, and 21 CFR 866.

The IVD classification will determine what type of premarket submission is required before you can begin to market your device in the US. Most Class I IVD products do not require a premarket submission and are 510(k) exempt. Most Class II IVD products require a 510(k) premarket submission.  A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device [21 CFR 807.92(a)(3)] that is not subject to premarket approval (PMA). For IVDs, the review of a 510(k) includes an evaluation of the analytical performance characteristics of the new device compared to the predicate, including the bias or inaccuracy of the new device, the imprecision of the new device, the analytical specificity and sensitivity.

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In most cases, analytical studies using clinical samples (sometimes supplemented by carefully selected artificial samples) are sufficient. For some IVDs, the link between analytical performance and clinical performance is not well defined; therefore, clinical information may be warranted.

For IVD products with no predicate device the De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. De Novo classification is a risk-based classification process. Through a De Novo Classification Request (De Novo request) devices are classified as either Class I or II and may be marketed and used as predicates for future premarket notification [510(k)] submissions.

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For Class III IVD products, Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness. A PMA is a much lengthier submission requiring not only data to show substantial equivalence, but information on the manufacturers quality management system.

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In addition to the premarket submission requirements, IVDs are subject to certain labeling requirements, 21 CFR 809, Subpart B, In Vitro Diagnostic Products for Human Use, compliance with the quality system regulation, 21 CFR 820, medical device listing and establishment registration, and medical device reporting requirements under 21 CFR 803.

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Folio Consulting Group, LLC has experience helping IVD manufacturers successfully complete their premarket submissions and gain access to the US market. Contact us today to help develop your regulatory strategy and file your 510(k), De Novo, or PMA.