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Medical Devices / Regulatory Affairs

FDA Aims to Encourage Consumer Access to Genetic Tests

Nov. 13, 2017
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The FDA has classified genetic health risk assessment systems as Class II with special controls, and is proposing to exempt the devices from premarket reviews.

Consumers are increasingly embracing genetic health risk testing to learn their individual risk for developing certain diseases, prompting some to make more informed lifestyle choices, noted FDA Commissioner Scott Gottlieb. 

The saliva-based tests require special controls to ensure that they can provide reasonable assurance of safety and effectiveness. By combining special controls with a premarket review exemption, the agency “seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight,” Gottlieb said.

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