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In vitro diagnostic devices are subject to FDA oversight before they can be legally marketed in the United States. The regulatory pathway depends on how your device is classified, what it measures, and where it is intended to be used. Since 2007, QSS has guided IVD manufacturers, importers, and international companies through the FDA regulatory process with clarity and confidence.
IVD devices are regulated as medical devices under the Federal Food, Drug, and Cosmetic Act. FDA classifies them into three risk-based categories and the classification determines which regulatory pathway applies. Most Class II IVDs require a 510(k) premarket notification before they can be marketed in the U.S.
What makes IVD regulation distinct is the analytical performance standard. FDA evaluates IVD submissions for the accuracy, precision, and analytical sensitivity of the device, not just substantial equivalence. A submission that does not address these dimensions will not clear review.
For international manufacturers, establishment registration, device listing, and U.S. Agent requirements apply before any device can be distributed. Getting the sequence right from the start protects your market entry timeline.
Before any submission work begins, we assess your device’s intended use, specimen type, and testing environment to determine how FDA classifies it. Classification drives every decision that follows, including pathway, submission type, and performance data requirements. Getting it right at the start avoids costly course corrections later.
Most Class II IVD devices require a 510(k) before reaching the U.S. market. We prepare the complete submission package, including device description, predicate selection, substantial equivalence argument, analytical performance data, and labeling, structured to FDA’s current guidance for in vitro diagnostic devices.
IVD 510(k) submissions require specific analytical performance data including accuracy, precision, and analytical sensitivity and specificity. We advise on study design, help interpret performance data, and structure the documentation to meet FDA’s expectations for the specific device category.
All IVD manufacturers and importers must register their establishment with the FDA and list their devices before marketing in the U.S. We guide manufacturers through the FURLS registration process, ensure device listings are complete and accurate, and manage annual renewal obligations.
FDA has specific labeling requirements for IVD devices, including intended use statements, instructions for use, and performance characteristics. We review IVD labeling for compliance with FDA requirements before submission and before products reach the U.S. market.
When an IVD device is genuinely novel and no valid predicate exists, the De Novo pathway may be the appropriate route to market. We evaluate De Novo eligibility for diagnostic devices and support the classification request where applicable.
FDA obligations for IVD devices do not end at clearance. Device modifications, labeling updates, and changes to intended use may trigger new submission requirements. We advise on post-market obligations and help manufacturers maintain ongoing compliance as their device portfolio evolves.
An in vitro diagnostic device is a medical device used to perform analysis on specimens derived from the human body, such as blood, urine, or tissue, outside of the body. IVDs include laboratory analyzers, point-of-care tests, reagents, and test kits used to detect conditions, measure biomarkers, or support clinical decisions. FDA regulates IVDs as medical devices under the Federal Food, Drug, and Cosmetic Act.
It depends on the classification of your device. Most Class II IVD devices require a 510(k) premarket notification before they can be legally marketed in the United States. Some Class I devices are exempt from premarket review but still require establishment registration and device listing. Class III IVD devices require Premarket Approval. A classification assessment is the necessary first step to determine which pathway applies to your specific device.
In addition to the standard substantial equivalence assessment, FDA evaluates the analytical performance of IVD devices. This includes the accuracy or bias of the device, its precision, and its analytical sensitivity and specificity. Performance data must be structured and presented in accordance with FDA’s current guidance for the relevant device category. Submissions that do not adequately address these dimensions are likely to receive deficiency requests.
Establishment registration identifies your facility to the FDA as a manufacturer, importer, or distributor of medical devices. Device listing identifies the specific devices your establishment manufactures or distributes. Both are required before an IVD device can be legally marketed in the U.S. and must be renewed annually. They are separate from the 510(k) submission process, though all three are typically required for a new market entrant.
Yes, but FDA requirements apply regardless of where the device is manufactured. International IVD manufacturers must complete FDA establishment registration, appoint a U.S. Agent, list their devices, and obtain the applicable premarket clearance or approval before distributing in the United States. QSS regularly works with international manufacturers navigating U.S. market entry for in vitro diagnostic devices.
FDA requires IVD device labels to include the intended use, instructions for use, performance characteristics, and storage conditions. Labeling must be accurate, not misleading, and consistent with the cleared indications. For point-of-care devices intended for home use, additional readability and usability requirements apply. Labeling review before submission helps avoid deficiency requests related to claims or format.
Device modifications after clearance may or may not require a new 510(k) submission, depending on the nature of the change. Modifications that could significantly affect safety or effectiveness, including changes to intended use, analytical performance, or labeling, typically trigger a new submission requirement. QSS advises on post-market modification obligations to help manufacturers stay compliant as their devices evolve.
Talk to a specialist about your IVD device registration pathway, whether you are determining classification for the first time or preparing a 510(k) for the U.S. market.