FDA defines the term
On November 16,
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:
|Manufactured in small volumes by local laboratories||Labs can now provide lab results nationally and internationally|
|Intended for Rare Diseases||Used widely to screen for common diseases|
|Relied more on manual techniques||Relies on instrumentation and software to generate results|
|Interpreted directly by physicians responsible for the patient||Used to make critical treatment decisions|
|Similar to standard diagnostic devices||
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