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?