At-Home DNA Tests

Test type

Genetic health risk tests: what FDA reviews

For people who want to know: my genetic risk for a disease.

What FDA says

First test reviewed; later tests exempt, with conditions

FDA: “GHR tests are intended to provide information on an individual's genetic risk for certain medical diseases or conditions.” (U.S. Food and Drug Administration) “The GHR tests are intended to provide genetic risk information to consumers, but these tests do not determine a person's overall risk of developing a disease or condition.” (U.S. Food and Drug Administration)

The regulation, 21 CFR 866.5950, sets the conditions for that exemption:

The genetic health risk assessment system device, when it has previously received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”), is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 866.9. The device must comply with the following special controls:

The limitation in § 866.9 restricts any such exemption: “The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality.” (21 CFR 866.9) The special controls include an opt-in step: “When the test reports the risk of a life-threatening or irreversibly debilitating disease or condition for which there are few or no options to prevent, treat, or cure the disease, a user opt-in section must be provided.” (21 CFR 866.5950) They also require the label to say that “other companies offering a genetic risk test may be detecting different genetic variants for the same disease, so the user may get different results using a test from a different company.” (21 CFR 866.5950)

A report offered under this exemption doesn't go through its own premarket notification, so it may not appear in FDA's database under its own number. The name lookup on this site can't tell you whether such a report meets the conditions.

FDA's page summarizes the arrangement:

Companies that offer DTC GHR tests are required to obtain FDA clearance prior to offering their first test. Companies may then offer most additional DTC GHR tests without FDA premarket review, provided they meet specific requirements that are described in the regulation for this type of test and are not for specific higher risk uses.

FDA records under product code PTA: five.

The federal rule

FDA classifies these tests under 21 CFR 866.5950, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a disease.” (21 CFR 866.5950)

What every home DNA result has in common

FDA: “No test is 100% accurate.” (U.S. Food and Drug Administration) MedlinePlus adds that “additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions.” (MedlinePlus)

Federal rules for genetic health risk tests note that “some people may feel anxious about getting genetic test health results. This is normal.” (21 CFR 866.5950)

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