By Jeffrey N. Gibbs —
On February 19, 2015, FDA granted de novo authorization to 23andMe for genetic tests for autosomal recessive traits that are offered directly to consumers (DEN140044). Nearly three years later, FDA has proposed a pathway that opens this avenue further. In a statement on November 6 announcing this action, Commissioner Gottlieb declared, “FDA [is] seek[ing] . . . an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight.”
The Federal Register notice setting forth the special controls for this new class of devices was not unexpected. FDA’s granting of de novo authorization of the 23andMe test meant that special controls would be issued some day. The surprise, perhaps, was that it took so long, especially since the proposed special controls so closely track the types of data that 23andMe submitted.
One aspect of the proposal, though, bears special attention. Typically, after de novo authorization other applicants either need to submit 510(k)s for all subsequent devices in that class (e.g., as happened with Philips’ digital pathology assay [DEN160056]) or are exempt (e.g., as happened after Widex was granted de novo status for wireless hearing aids [DEN100025]). This time, FDA proposed that a company offering a test would need to obtain a 510(k) for its first test, but then subsequent tests within the class would be exempt. FDA has called this “a one-time FDA reviewed genetic health risk assessment.” Thus, in deciding whether to invest in seeking an initial 510(k), companies should consider what other tests within the classification can be added later on without a new submission.
There may be some question as to whether a particular test does fall within the regulation. The definition is not as precisely worded as many other classification regulations: “qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease to inform lifestyle choices and/or conversations with a health care professional . . . .” This “squishy” reference to “lifestyle choices” and “conversations” is not typical in defining a device classification.
The proposal does not mention one of the most controversial regulatory topics in diagnostics (or devices): FDA’s authority to regulate laboratory developed tests (LDTs) (see our previous posts here and here). Yet lurking in the background in this proposal is FDA’s view that it does have the power to regulate LDTs. If it didn’t, then a laboratory could offer an LDT genetic test directly to consumers without FDA oversight. FDA, though, has repeatedly stated that direct-to-consumer LDTs are not entitled to enforcement discretion. In the past, FDA has been attacked for trying to regulate LDTs by guidance. Here, FDA is proposing a regulation that establishes regulation of a type of LDT – direct to consumer genetic tests – albeit in an oblique fashion.
On its face, the regulation would be agnostic. It would apply to tests offered at a site regardless of whether it qualified as an LDT. Nevertheless, the tests most likely to be subject to regulation under this new classification are LDTs, not genetic tests based on commercial assays.
For labs that decide to pursue this route for their LDTs, the proposal can offer some benefits. Tests that are covered by this regulation could be ordered directly by consumers without the need for any medical review. That can save costs and reduce the administrative burden. Also, FDA clearance would allow the tests to be sold in those states where direct-to-consumer LDTs are currently problematic.
Comments on the proposal are due January 8, 2018. While the proposal may seem innocuous on its face, potentially affected stakeholders should carefully think through the consequences and implications of this action, as well as whether they have concerns about the scope of the regulation or the proposed special controls.