FDA exempts select genetic risk tests from 510(k) requirements

The FDA has exempted some genetic health risk assessments from the agency's premarket notification — or 510(k) — requirements, effective June 5.

A 501(k) is a premarket notification a company submits to the FDA to demonstrate its class I, II or III medical device is as safe and effective as an existing legally-marketed device. Under the FDA's final order, published on the Federal Register June 5, genetic risk tests that have already received a first-time FDA marketing authorization will not need 501(k) clearance.

The order aims to streamline the regulatory process for genetic tests that estimate a person's risk for select health conditions, such as those offered by direct-to-consumer genetic testing provider 23andMe. However, the FDA laid out a number of requirements for products in this category, including stipulations related to consumers' comprehension of their results.

To ensure the results of a genetic risk test are presented in an easily understandable way, the FDA now requires companies offering these products to conduct user comprehension studies. The comprehension studies will aim to assess how well potential users understand the product's processes and results.

The FDA also added labeling requirements for over-the-counter genetic risk tests, which detail answers to frequently asked questions, available professional guidelines and how to access a genetic counselor.

"Consumer understanding of genetic risk is clearly an important issue that was considered extensively by FDA in the context of genetic health risk assessment system devices," the final order reads. "This issue was balanced with the increasing desire from the public to learn more about one's own genetic makeup and how it affects genetic risk for health conditions."

To access the FDA's final order, click here.

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