Getting Approval This is especially true for the complex tests regarded by the FDA as “new and novel,” which are subject to the highest standards of proof of their safety and effectiveness, according to Fred Lasky, PhD, director of diagnostics compliance for Ortho-Clinical Diagnostics, a division of Johnson & Johnson in Rochester, NY.
Medical devices, including laboratory tests, are classified by the FDA based on the level of control necessary to assure the safety and effectiveness of the device. Devices that support or sustain human life, present a potential or unreasonable risk of illness, or can greatly prevent human health from being impaired fall into FDA’s most stringent category, Class III, and must demonstrate reasonable assurance of safety and effectiveness before being approved for marketing in the US. Examples of Class III devices in the laboratory are the
in-vitro diagnostic tests used to detect antibodies for the Hepatitis C virus, which, if untreated, can lead to chronic liver disease, and in vitro diagnostic tests used to diagnose cancer.
By comparison, a simple
blood test to determine uric acid concentrations in serum has “a long history that is well understood, and there are convenient means for a laboratory to control or monitor how the test is performing,” said Dr. Lasky. In addition, the test, which falls under the Class I category, provides supportive evidence to a physician’s preliminary diagnosis of
gout, a nonfatal and generally treatable disorder.
Besides assessing the potential risk to the patient, 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. Under the 1976 Safe Medical Device Act that established the FDA’s regulation of medical devices and tests, manufacturers are required to notify the agency of their intent to market a new product. The FDA permits most Class I and II medical devices to be marketed after the manufacturer can demonstrate that the device is “substantially equivalent” or as safe and effective as a similar device already on the market.
Devices or tests that have a new use or that pose new issues of safety and effectiveness 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.
As an example of a PMA, in December 1998, the FDA granted approval to Vysis, Inc., a genomic disease management subsidiary of Abbott Laboratories, Abbott Park, IL, to market a testing kit that can detect
amplification of the HER-2 gene from human breast cancer tissue specimens. Detection of multiple copies of this gene in patients is important since these patients tend to experience rapid tumor growth, resistance to therapy, and decreased survival rates. Early detection can allow physicians and patients to choose the most beneficial form of treatment, according to the company.
For more complete coverage of these classes, see the
sidebar on FDA Classifications of Medical Devices. A summary table follows.
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Class I |
Most 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 II |
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 |
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Class III |
Require FDA approval; often involve agency review of clinical data |
