Blog | The FDA Group

New Regulations for Lab-developed Tests

Written by The FDA Group | August 11, 2014

On July 31, 2014, the Food and Drug Administration announced to Congress that it will begin to regulate tests developed in a laboratory. These tests consist of those developed on a small scale in small laboratories. They include microscopic examinations (eg, Papanicolaou tests), examinations of sections of tissue, microbiology cultures, susceptibility tests, and erythrocyte sedimentation rates. They are used to diagnose conditions such as cancer, diabetes mellitus, heart disease, and Lyme disease. They differ from other manufactured tests, which are distributed to physician’s offices and are subject to regulations. This announcement is part of the agency's efforts to standardize such tests and make them safer and more reliable.

 

According to the Food and Drug Administration, these regulations are being developed because circumstances surrounding the nature and distribution of the tests have changed. Previously, these tests were developed in hospitals and other local clinics exclusively to assess conditions in patients receiving treatments there. They used to be relatively simple tests, such as cholesterol screening; however, in recent years they have become more complex. For instance, some laboratories have developed tests elaborate enough to detect biomarkers for certain types of cancer. These tests are also starting to be marketed outside of these hospitals. As such, manufacturers of commercially available tests have complained to Congress that because these local tests are less expensive, competing with them is challenging.

Moreover, there have been concerns regarding the accuracy of these tests. Although proponents of these tests claim that they undergo rigorous in-house testing, critics claim that there is a question about the accuracy of these assessments because they are not subject to federal testing standards. Some have argued that these tests are ineffective or provide inconclusive results. As such, some patients may choose not to take these tests or delay taking them. Advisory committees, such as the Institute of Medicine, have recommended that the Food and Drug Administration provide more oversight of these tests. The Food and Drug Administration is also concerned that faulty tests could result in diseases being overtreated or undertreated; patients receiving inappropriate, ineffective, or harmful therapies for diseases; and conditions being incorrectly diagnosed.

The proposed framework is similar to the current regulation for in vitro diagnostic devices. The framework describes how the Food and Drug Administration intends to enforce premarket approval and postmarketing surveillance of these tests and how the Food and Drug Administration intends to phase in regulatory laws related to these tests. Proposed measures include premarket reviews; evaluation of the risk of the test in a manner similar to the current device classification system (Class 1, 2, or 3); and measures for reporting adverse events. The regulations would apply to tests that compete with manufactured tests, tests that perform the same role as that of high-risk medical devices, and tests used to screen blood. However, they would not pertain to tests for extremely rare diseases for which there is no other approved option.

Within sixty days, the Food and Drug Administration will issue a draft guidance regarding the regulation of these tests. Manufacturers will be able to provide input on this guidance for ninety days after it is issued. The Food and Drug Administration also plans to hold a meeting during the ninety-day period to discuss any questions and concerns. This meeting will be announced on the Federal Register notice.

 

For Further Reading

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM407409.pdf