FDA Announces New Premarket Notification Exemptions

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.

Renee Balliet, Scientific Director, Precision Medicine

Renee Balliet has over 10 years of experience in the field of genetics and molecular diagnostics, including: evidence evaluation, analysis, and synthesis; leadership and advising; business development; scientific/medical project management; development, presentation, and marketing of scientific information; and preclinical research.

We use cookies and other tracking technologies to improve your browsing experience on our website, to show you personalized content and targeted ads, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies.
Thanks for signing up. You must confirm your email address before we can send you. Please check your email and follow the instructions.