Skip to main content

FDA Preliminary List of 510(k) Exempt Devices Bodes Well for Genomic Tools Providers

This article has been updated with additional information from the FDA regarding the scope of the proposed premarket notification exemptions. 

NEW YORK (GenomeWeb) – The US Food and Drug Administration has identified more than 1,000 Class II devices that it plans to exempt from 510(k) premarket notification requirements, including a number of genomic analysis instruments.

The draft list, published in the Federal Register earlier this week, includes such items as "high throughput DNA sequence analyzer," "DNA genetic analyzer," "mass spectrometer for clinical multiplex test systems," "real time nucleic acid amplification system," "complete gene expression profiing accessory reagents," and quality control DNA materials. 

This would exempt certain analyzers "that fit within the discription in regulations and that meet special controls," an FDA spokesperson said. For example, Illumina's MiSeqDx next-generation sequencing system fits the description of "high throughput DNA sequence analyzer," described under regulation 862.2265. FDA granted 510(k) clearance to MiSeqDx with special controls in 2013.

Generally, the FDA requires premarket review of the test and the instrument it runs on, but has been making efforts in recent years to lessen the burden on labs. For example, Illumina received FDA clearance for its MiSeqDx system, two cystic fibrosis assays, and a library prep kit. However, the agency approved the MiSeqDx system as a Class II device with "special controls," so other labs with tests that run on the same system and with the same intended use could complete the requirements outlined in the special controls and commercialize the tests without submiting them for premarket review. 

According to the latest Federal Register notice, even when platforms are exempt from premarket notification, sponsors would still have to meet other regulatory requirements for these devices, such as following good manufacturing practice procedures.

Moreover, the notice doesn't exempt in vitro diagnostic kits and companion diagnostics that use these instruments from premarket review. However, laboratory-developed tests can continue to be offered through CLIA-certified labs, since the FDA decided to hold off on finalizing its oversight plan for LDTs last year.

"This approach by the FDA is good for both Illumina and the industry more broadly as it allows for a faster but still appropriate path to market for instruments," Mya Thomae, Illumina's VP of regulatory, clinical, and medical affairs, said in an email. "It also lightens the FDA's work load as they can now focus on the assays, which we believe … will still undergo the usual review process."

Although the agency has decided to continue enforcement discretion for LDTs for the time being, the agency maintains that these tests aren't sufficiently regulated under CLIA and place the public health at risk. "This announcement doesn't address the long standing LDT issue directly but it does partially address the FDA's concerns around LDTs in that this may provide larger access to IVD labeled instruments for those labs creating LDTs," Thomae added.

Market analysts also saw the latest notice from the FDA as a positive development for NGS platform providers. In a note to investors, Piper Jaffray analyst William Quirk wrote that if genomics tools remain on the FDA's final list of 510(k) exempt devices, then it "will free companies like Illumina to push their life sciences innovation faster into the clinic" and improve inventory management by not having to sell older systems, such as MiSeqDx.

The fact that DNA quality control materials are also on the list of exempt devices also bodes well for the R&D budgets of companies that provide such products, including Thermo Fisher Scientific, Bio-Rad, and Bio-Techne, Quirk added.

The FDA produced the list as part of its commitments under the 21st Century Cures Act, and is accepting public comments on the proposed list until May 15. A final list of exempt devices is slated for July 11.