On July 11, 2017, the FDA announced Exemptions from Premarket Notification: Class II Devices. The list, which includes more than 1,000 class II devices, includes genomic platforms and tools:
- High-throughput DNA sequence analyzer
- DNA genetic analyzer
- Mass spectrometer for clinical multiplex test systems
- Real-time nucleic acid amplification system
- Complete gene expression profiling accessory reagents
- Quality control DNA materials
So what does this mean for genetic tests?
“Overall, there is currently not a major immediate impact on most genetic tests.”
This is a win for companies that produce platforms, including widely used next-generation sequencing (NGS) platforms and companies that produce DNA quality control material. However, in vitro diagnostic kits and companion diagnostics that use these instruments are not exempt from premarket review. In addition, the vast majority of the more than 65,000 tests currently available fall under laboratory developed tests (LDTs), which means they are developed in a single lab for use in that specific lab and are not subject to the FDA’s premarket requirements. Since LTDs are run in laboratories, they fall under the regulation of the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and for which the FDA can use discretionary enforcement. Overall, there is currently not a major immediate impact on most genetic tests.