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# FDA Offers ‘Flexible’ Approach for Genetic Health Risk Tests
- URL: https://www.fdaweb.com/fda-offers-flexible-approach-for-genetic-health-risk-tests/
- Published: 2017-11-06T12:00:00.000Z
- Updated: 2026-09-14T23:00:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140054

FDA wants to implement a novel regulatory approach for direct-to-consumer genetic health risk (GHR) tests that will use “flexible” oversight similar to the model used for digital health technologies ([see earlier story](https://www.fdaweb.com/new-fda-digital-health-steps/)). The agency is issuing a *Federal Register* [notice 11/7](https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-24163.pdf?ref=fdaweb.com) proposing to allow GHR tests to be exempted from premarket review under certain conditions. “If and when finalized, manufacturers of these types of tests would have to come to FDA for a one-time review to ensure that they meet the FDA’s requirements, after which they may enter the market with new GHR tests without further review,” FDA commissioner **Scott Gottlieb** is quoted as saying in a [release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583885.htm?ref=fdaweb.com). The agency has also established special controls for these tests in a separate [*de novo classification order*](https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-24159.pdf?ref=fdaweb.com) for 23andMe’s Personal Genome Service (PGS) Test, “which outline requirements for assuring the tests’ accuracy, reliability and clinical relevance and describe the type of studies and data required to demonstrate performance of certain types of genetic tests,” he said.

Since taking office six months ago, Gottlieb appears to be reshaping how FDA regulates many products. Under FDA’s [precertification pilot program](https://www.fdaweb.com/new-fda-digital-health-steps/), which the GHR test proposal is being modeled after, the agency “seeks to apply a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product,” according to the commissioner. “Another example is the FDA’s forthcoming, comprehensive policy framework that will more clearly describe some novel frameworks for how the agency intends to regulate the safety and effectiveness of cell-based regenerative medicine.”

In its new notice, FDA says that a “one-time FDA review (e.g., premarket notification) of a genetic health risk assessment system is necessary to provide reasonable assurance of the safety and effectiveness of the device.” Furthermore, the one-time review is “necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the agency to assess the safety and effectiveness of the devices and the regulatory controls necessary to address those issues as well as to ensure the devices perform to acceptable standards.”

“We’ll continue to look for opportunities to use this type of firm-based regulatory approach, both for new tests and other novel medical products,” Gottlieb said. “Our goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek.”