Should the FDA Regulate Laboratory Developed Tests?

FDA defines the term laboratory developed test (LDT) as an in vitro diagnostic test (IVD) that is intended for clinical use and designed, manufactured and used within a single laboratory.  In 1976, the Medical Device Amendments (MDA) was enacted and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a system for the regulation of medical devices intended for human use.  Although considered IVDs, the FDA chose to exercise enforcement discretion for LDTs with the justification that these tests were relatively simple, used only in the lab that developed the tests and were used for rare conditions. 

On November 16, 2015 the FDA released a report The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies which demonstrates how the lack of LDT oversight may be causing significant harm to patients.  The report focuses mostly on false-positive tests, resulting in unneeded treatment, and false-negative results, where diseases went undetected.  This follows the draft guidance Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), released October 3, 2014, in which the FDA discussed a framework for addressing the regulatory oversight of LDTs.  The document is intended to provide guidance to clinical laboratories that manufacture LDTs about how FDA intends to enforce regulations as medical device manufacturers. 

The FDA believes that the combinations of the following changes since the Medical Device Amendments of 1976 were enacted have resulted in a significant increase in potential risks to patients: 

The Centers for Medicare & Medicaid Services (CMS) has regulated laboratories under the Clinical Laboratory Improvement Amendments (CLIA) since 1988.  Although CLIA addresses the laboratory testing process, the accreditors do not evaluate test validation prior to marketing or test accuracy.  FDA now finds that in the absence of appropriate oversight of LDTs, there is potential for increased risk for patients. 

However, some arguments against FDA oversight of LDTs include that oversight of such tests would greatly decrease the amount of critical diagnostic tests that are only available as in-house laboratory tests. Regulation by FDA is seen by some as unnecessary and would increase the cost and time needed to develop tests.  This could discourage laboratories from developing new tests.  Also, it has been argued that LDTs do not fit under the definition of a “device” and therefore the FD&C Act should not regulate these tests, stating that the devices are not classified based on functionality, but rather on a manufacturer commercially distributing the devices.

FDA regulations may hinder development of LDTs by increasing cost and time needed to develop these tests.  At the same time, the regulations could ensure that LDTs are being properly validated before being used in a clinical setting.  Do you feel that the same FDA regulations that apply to other IVDs should also be applied to LDTs in order to ensure that these tests are safe and effective?