FDA IVD Classification
The FDA IVD classification is based on the level of risk they pose to the patient and or user. This classification system is intended to ensure that the level of regulatory control is commensurate with the level of risk associated with the IVD’s intended use.
- Class I
- Class II
- Class III
According to 21 CFR 809.3, In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in collecting, preparing, and examining specimens taken from the human body.
According to 21 CFR 809.3, In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in collecting, preparing, and examining specimens taken from the human body.
FDA IVD Classification with Examples
Class I: General Controls
Class I devices are subject to the least regulatory control. They are considered low-risk devices and are subject to general controls to ensure safety and effectiveness. These controls include provisions related to good manufacturing practices, proper labelling, and device registration.
Example: Clinical laboratory reagents, Complement reagents, General purpose laboratory equipment (Buffered saline solutions used for general laboratory procedures, Pipettes, and test tube racks, Some reagents and Urine Pregnancy Tests
Regulatory Requirements: Most Class I devices are exempt from premarket notification (510(k)), meaning they do not require FDA review before being marketed.
Class II: General Controls and Special Controls
Class II devices are at higher risk than Class I devices and require additional regulatory controls to provide reasonable assurance of their safety and effectiveness. These special controls can include performance standards, post-market surveillance, patient registries, and FDA guidelines.
Examples: Immunological test systems, Blood glucose test systems and Certain pregnancy tests.
Regulatory Requirements: Class II devices typically require premarket notification (510(k)), where the manufacturer must demonstrate that the new device is substantially equivalent to a legally marketed device.
Class III: General Controls and Premarket Approval
Class III devices are considered the highest risk and are subject to the most stringent regulatory controls. These devices are usually life-sustaining, life-supporting, or of substantial importance in preventing impairment of human health.
Examples: HIV diagnostic tests, Automated PAP smear readers, HIV diagnostic tests, Blood donor screening tests for infectious diseases, and cancer markers to diagnose and monitor cancer.
Regulatory Requirements: Class III devices require premarket approval (PMA), a rigorous process that includes providing clinical data to support claims of safety and effectiveness.
If you’re a manufacturer or specification developer seeking approval for an IVD device, you’ll need to submit a 510k application to the FDA.
We specialize in assisting medical device manufacturers and specification developers in efficiently preparing and submitting their 510k files to the FDA, reducing the likelihood of receiving an initial “Refuse to Accept” (RTA)
FDA IVD Classification Specialties
The US FDA has established classifications for approximately 1700 different generic types of devices and categorized them into 17 medical specialities. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Among the 17 medical specialities, In vitro diagnostic device-related specialities are the following
- Chemistry,
- Hematology,
- Immunology,
- Microbiology,
- Pathology,
- Toxicology
USFDA References:
- 21 CFR 862 – Clinical Chemistry And Clinical Toxicology Devices
- 21 CFR 864 – Hematology And Pathology Devices
- 21 CFR 866 – Immunology And Microbiology Devices
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Laboratory based IVD tests
For laboratory-based tests, samples are sent to a laboratory for analysis. Often, this is required for complex conditions like cancer, HIV and hepatitis. Other examples of such tests and devices include:
- Blood grouping devices
- Human genetic tests
- Immunoassays
- Next-generation sequencing tests
Point of care IVD tests
This type of test is performed at, or near to, the point of patient care. This allows for a quicker diagnosis and speeds up the treatment decision-making process. In areas with little to no access to laboratory equipment and infrastructure, these point-of-care tests can help to improve patient care and reduce the cost of testing. Examples of this type of test include:
- Blood glucose self-monitoring systems
- COVID-19 tests
- Pregnancy tests
- Urinalysis test strips
IVD Instruments
- Clinical chemical analysis instruments,
- Immunochemical analysis instruments,
- Blood analysis instruments and
- Microbiological analysis instruments if according to the diagnostic methods and objects.
IVD Reagents
General purpose reagent: (21 CFR 864.4010) General purpose reagents are chemicals or biological materials used in a variety of laboratory applications, including IVDs, but are not specific to any diagnostic test. These reagents are utilized in the preparation, processing, and analysis of samples across multiple tests and disciplines.
Examples of GPRs include: Buffers, Solvents, Stains and Diluents
GPRs are broadly applicable and are not intended for use in detecting a specific analyte or performing a specific test. Because of their versatility, they are regulated less stringently compared to ASRs.
Generally considered low-risk, GPRs are regulated under the general controls of the Federal Food, Drug, and Cosmetic Act (FD&C Act). They do not require premarket approval or clearance but must comply with labelling and manufacturing practice standards.
- Class I (general control) exempt from 510k
- A chemical reagent that has general lab applicability
- It is not intended for specific diagnostic application
- It does not include lab machines, or automated or powered systems.
Analyte specific reagents: (21 CFR 864.4020)
Analyte-specific reagents are more specialized than GPRs and are used to detect or measure specific substances within a sample. These reagents are critical components of diagnostic tests and are tailored to identify specific markers or analytes, such as proteins, nucleic acids, or other molecular entities.
Examples of ASRs include Monoclonal antibodies, Nucleotide sequences (probes), Antigens
ASRs are designed to interact with specific targets in the sample, making them crucial for diagnostic accuracy. Due to their specificity and role in diagnostic tests, ASRs are subject to more stringent regulatory controls than GPRs.
ASRs are regulated under 21 CFR 809.10 and are subject to specific labelling requirements, including a statement indicating that the product is an ASR. They are used by clinical laboratories to develop laboratory-developed tests (LDTs) and must meet certain performance standards.
- These are antibodies, both polyclonal and monoclonal, ligands, specific receptor proteins, chemical reactions with substances in a specimen
- Classified according to device risk
- Intended for specific diagnostic application
- Used for identifying & quantifying individual chemical substances or ligands in biological specimens.
Working with I3CGLOBAL enables manufacturers to identify correct FDA IVD classifications and prepare the file more efficiently and effectively, ultimately speeding up the IVD 510k approval process.
Frequently Asked Questions
What is dual submission for IVD devices?
A dual submission for In Vitro Diagnostic (IVD) devices involves seeking both 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver simultaneously. This approach can significantly expedite the approval process, but it requires careful planning and execution.
How does FDA IVD Classification work for software as a medical device (SaMD)?
Software that functions as an IVD by analyzing medical data to make clinical decisions by a clinician /practitioner/patient may be classified based on its risk level. The FDA evaluates SaMD based on its intended use and potential impact on patient outcomes.
What is the role of clinical evidence in FDA IVD classification?
It’s crucial, particularly for Class III devices. It demonstrates that the IVD is safe and effective for its intended use. For lower-risk devices, less clinical data may be required.
How IVD device are identified?
- The general description of the device and its intended use, user and environment.
- Description of the components (e.g. reagents, assay controls, calibrators, cassette, etc.) and where appropriate, a description of the reactive ingredients of relevant components (such as antibodies, antigens, nucleic acid primers, probes, etc.).
- General description of the assay method or instrument (electrical/electronic).
- General description of software/firmware and its role if the device integrates with it.
- Description of the instrument(s) required to perform the test.
- If applicable, labelled pictorial representation (diagrams, photos, drawings).
What resources help with the FDA IVD classification? Does it possible to ask?
Refer FDA provides guidance documents and webinars on this subject. It is recommended to use the consultation services from I3CGLOBAL to help manufacturers understand the FDA IVD classification process. The FDA’s website also offers databases for device classification.