Originally Published: September 19th, 2014
Will Laboratory-developed tests (LDTs) require FDA marketing approval?
Laboratory-developed tests (LDTs) are in vitro diagnostic tests typically used within a single-institution’s CLIA lab. The FDA exempted clinical laboratories from registration and listing of tests almost 40 years ago; however, this exemption may no longer apply if the FDA’s new guidance document is implemented. In this guidance document, Framework for Regulatory Oversight of LDTs (July 31, 2014), the FDA proposes regulating LDTs in a similar manner to how it currently regulates IVD manufacturers.
The original intent behind the lack of strict regulation of LDTs was that these tests were part of the “practice of medicine”, which the FDA doesn’t regulate. Traditionally, LDTs were straightforward, well-understood tests (e.g. Pap smears, microbiology cultures) or tests to diagnose rare diseases in very specific populations. The tests were intended to be used within a single institution under the guidance of a physician. Also, LDTs have not been totally exempt from regulation, as Clinical Laboratory Improvement Amendments (CLIA) mandates certain performance standards.
However over time, LDTs have become more complex and have moved into areas competing with other tests that require FDA-approval, such as personalized medicine and genetic testing. Because of this shift, the FDA began to believe that LDTs could pose a risk of injury to the patient through incorrect or missed diagnoses and subsequently, inappropriate treatment.
In the latest guidance document, the FDA proposed several changes, based on the risk of the device.
|Low risk/ Rare diseases||Luteinizing hormone testLab reagents||Similar to a Class I device.Required registration and listing with FDA within 6 months of guidance implementation.Meet adverse event reporting standards within 6 months of guidance implementation.|
|Medium||Blood chemistryGlucose tests Coagulation tests||Similar to a Class II device.Meet requirements for Class I device.Undergo premarket preview starting five years after guidance is implemented.Meet medical device current good manufacturing practices (cGMP) under 21 CFR 820.|
|High||Companion diagnosticsPSA testing||Similar to a Class III device.Meet requirements for Class II device.Required to submit a PMA within one year (very high risk) or four years (lower high risk) of the guidance implementation|
*Forensic testing and some organ transplant diagnostics will not be subject to these regulations.
At this point, reaction to the guidance by many groups (particularly groups representing CLIA labs and physicians) has been negative, and there are likely to be challenges to implementing this guidance. Stay tuned as the controversy develops.
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