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FDA Sets Genetic Health Test Review Process

Stethoscope on DNA sheet

(National Heart, Lung, and Blood Institute)

6 November 2017. The U.S. Food and Drug Administration is proposing new review requirements for genetic tests of health risks that providers market directly to consumers. The new review policy is described in a statement by FDA commissioner Scott Gottleib published today on the agency’s web site.

The new procedures are outlined in draft orders, also posted today on FDA’s site, and scheduled to appear tomorrow for public comment in the Federal Register. One order classifies genetic health risk tests as class 2 medical devices — diagnostics are included with medical devices for regulatory purposes — indicating they require some regulatory review, but not necessarily the same level of intense scrutiny as devices directly affecting a person’s health, such as a heart pacemaker. The order also calls for special controls be applied to genetic health risk tests, since the diagnostics in this case cannot be adequately reviewed with the agency’s general rules.

The special controls for genetic health risk, or GHR, tests, according to the order, are a series of caveats provided with literature about the tests indicating the tests cover only a specific set of variations and are not a comprehensive genomic sequencing. Other caveats required are other vendors may provide different results, lifestyle and environmental factors could affect developing the condition being tested, information on finding genetic counseling, and a reminder that genetic testing is not a substitute for regular physician visits.

The order also calls for applying a De Novo classification process for new types of tests, for which there are no similar tests reviewed previously. Under the law, a device is automatically put into the highest-risk category, class 3 devices, if there’s no equivalent device for comparison. A De Novo classification makes it possible for FDA to review the device under a lower-risk category.

FDA’s Gottleib envisions the new procedures will enable genetic health vendors to need only a single review of their processes by the agency, thus bypassing the need to review each individual test as its issued. “If and when finalized,” notes Gottleib, “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.”

Gottleib cites the agency’s experience with digital health technologies as a precedent for the new procedures. The Software Precertification Pilot Program, or PreCert, is a voluntary initiative, where FDA evaluates the developer of software or digital health technology rather than each individual product. In June 2017, Science & Enterprise reported on the agency’s intention to undertake this program, noting FDA would, for example review a company’s software design, testing, and maintenance, which could then be certified for consistency and reliability.

Also in today’s announcement, FDA issued draft orders exempting genetic carrier screening tests from premarket review by the agency, and classified total 25-hydroxyvitamin D mass spectrometry test systems used to assess vitamin D status as class 2 devices subject to special controls. Both orders are set to appear tomorrow in the Federal Register.

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