DTC Genetic Health Risk Tests Exempted from FDA 510(k) Requirements

Regulatory NewsRegulatory News | 01 June 2018 |  By 

Manufacturers of direct-to-consumer (DTC) genetic health risk (GHR) assessment systems were directed to withdraw pending 510(k) submissions to the US Food and Drug Administration (FDA) as this device type is now exempt from premarket notification.
Exemptions from 510(k) requirements “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain federal regulations,” FDA’s Center for Devices and Radiological Health (CDRH) said in an immediately in effect order issued Friday.
CDRH’s new order finalized the November 2017 proposed exemptions for DTC genetic tests, as well as four other device types, including total 25-hydroxyvitamin D mass spectrometry test systems and endoscope disinfectant basins. Firms of these device types are now only required to undergo a one-time regulatory review prior to legally entering the US market, though other requirements under the new regulation must be met. 

A comment CDRH received opposed to subjecting DTC genetic tests to a single review, arguing that the proposal “will not prevent scientifically invalid tests from being marketed to the public and lacks a comprehensive assessment.” These concerns were thwarted as CDRH believes the specified controls are sufficient to provide reasonable assurance of safety and effectiveness.
Under the new classification regulation, firms must comply with special labeling requirements on the DTC genetic tests, which include having information available to consumers online. Other components of the regulation involve an accuracy threshold of at least 99% for all genetic variants.

Certain situations may cause a test to fall outside the regulation's scope, such as prenatal testing. The test must also be intended to facilitate informed lifestyle decisions in consultation with healthcare professionals.

The regulation was developed based on FDA’s past experience with and knowledge of the device type, beginning with a premarket submission from 23andMe. A De Novo classification request submitted by the genetic test developer in 2016 got the ball rolling with the new regulatory approach on GHRs—aimed at supporting greater patient access to the device type.
Earlier this year, 23andMe also received a first-ever FDA authorization on a DTC test for three cancer-associated genetic variants, which was also reviewed via the De Novo pathway.
Last month, the center also finalized a proposed exemption on surgical apparel. The plethora of 510(k) exemptions is part of larger efforts to pull back on regulations—as prompted by provisions in the 21st Century Cures Act of 2016—with exemptions from premarket notification listed for more than 1,000 class II device types, such as the endoscopic magnetic retriever.
Medical Devices; Exemptions From Premarket Notification: Class II Devices


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