New rules issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers (DTC), without a health-care provider intermediary.
The first rule exempts "autosomal recessive carrier screening gene mutation detection systems" that are offered DTC from FDA premarket review. FDA first proposed this exemption in 2015, on the same date as the agency issued a final order classifying these types of tests as Class II medical devices, in response to a request from 23andMe. The 2015 final rule specified the conditions under which all companies could offer autosomal recessive carrier tests directly to the public. By finalizing the exemption, FDA is permitting companies to offer these tests DTC without the need for prior FDA review. These companies will still be subject to general requirements applicable to all medical device manufacturers, as well as to the "special controls" specified by FDA for these types of tests in the final rule.
Similarly, the second rule finalizes a new medical device classification for DTC "genetic health risk assessment" (GHR) (i.e., predictive) tests. The classification specifies the conditions under which these tests may be marketed, and includes the requirement for a 510(k) premarket notification to FDA. However, in a Federal Register Notice, also issued yesterday, FDA proposes to exempt GHR tests from the 510(k) premarket submission requirement after a company has successfully obtained FDA clearance of its first GHR assay, and provided that the company continues to follow the specified special controls for this class of tests. Comments to this proposed exemption are being accepted by FDA until January 8.