FDA Classification and Requirements for Approval
Under the 1976 Medical Device Amendments that established the FDA's regulation of medical devices and tests, manufacturers are required to notify the agency of their intent to market a device. This allows the FDA to classify the device. This classification determines the process by which medical devices, including laboratory tests, are cleared or approved by the FDA.
The FDA classifies laboratory tests based on the level of control needed to assure that the device is safe and effective. Laboratory tests that pose substantial risk of harm fall into the most stringent category and are subject to the highest standards of proof of their safety and effectiveness. These typically require the most time and resources to gain approval. That is why you may read or hear about an experimental test, but it does not become available or used in clinical practice for several months or even years later. By comparison, devices that pose little risk to human life and are generally not as complicated are exempt from FDA review.
FDA approval is also based on the intended use or uses of a test as stated by the manufacturer. An intended use of a test can be for screening or for diagnosis, or for certain populations, such as children or women, as examples.
The other factor used to classify tests is the FDA's familiarity with the test process itself and the medical devices and equipment used to produce the result. If a manufacturer can demonstrate that a device is "substantially equivalent" or as safe and effective as a similar device already on the market, the FDA permits the device to be marketed. Devices or tests that have a new use generally require more time and resources for approval.
Laboratory tests fall into one of three categories for FDA clearance and approval to market:
These devices present minimal potential for harm to the user and are often simpler in design than either Class II or Class III devices. Most Class I tests are exempt from FDA review of submissions, although a manufacturer must still register with the agency, list the products in commercial distribution, and make those products according to Quality Systems Regulations (formerly, Good Manufacturing Practices).
Class I devices are those that can be monitored by general controls. Some of the general controls that the FDA uses are: 1) the device must be registered with the FDA; 2) devices must be manufactured using Quality Systems Regulations; 3) the labeling of the device must at least tell the user the product name, intended use, type of procedure it is, and - if it is an instrument - installation, operating, and maintenance procedures; and 4) the manufacturer must submit a 510(k) pre-market notification before marketing the device or test.
Examples of Class I tests are point-of-care tests (POCT), those that that are performed at or near a patient and at the site where care or treatment is provided. Point-of-care tests are typically designed to be simple to use. Examples include a rapid strep test performed at a healthcare practitioner's office or glucose meters for diabetes.
Class II devices and tests are ones for which the general controls have not been deemed sufficient to ensure safety and effectiveness; therefore, they are subject to special controls such as special labeling, mandatory performance standards, and post-market monitoring.
These tests often require pre-market notification under the 510(k) process in which the company submits data on analytical performance relative to a "predicate device" (a device already on the market for a similar intended use); clinical data are sometimes needed to support a manufacturer's intended use.
This class includes assays that may test for the same analytes as Class I tests, but typically use more sophisticated instrumentation to do so. Laboratory instruments, such as automated CBC devices, are in this class, for example, as well as automated instruments that perform an array of chemistry tests, such as glucose, electrolytes, BUN, and creatinine.
This is the most stringent category. This class includes tests that have a new use or for which there is not enough information about their safety and effectiveness to protect the public with just general or even special controls and/or tests that are of substantial importance in preventing impairment of human health.
These tests generally require submission of a pre-market approval (PMA) application with valid findings from human clinical trials that demonstrate that the device is clinically effective for its intended use. In addition to reviewing and approving the clinical data from the company-sponsored trials, FDA also confirms that the device will be manufactured in conformance to good manufacturing practices.
Examples of Class III tests include hepatitis B and hepatitis C tests and cancer tests, such as the epidermal growth factor receptor (EGFR) gene mutation test that is used to help guide treatment of non-small cell lung cancer (NSCLC).
To learn more about the FDA's clearance and approval process for laboratory tests, visit the FDA webpage on Medical Devices.