On June 5, 2018, FDA published a notice in the federal register finalizing the 510(k) exemption for several devices. The proposed list for 510(k) exemption was published last November and included two new devices that had been granted marketing authorization through the de novo process earlier last year. These were the total 25-hydroxyvitamin D mass spectrometry test system (21 C.F.R. § 862.1840) and genetic health risk assessment system (21 C.F.R. § 866.5950).
The de novo reclassification letter for the total 25-hydroxyvitamin D mass spectrometry test system (DEN170019) specifically noted FDA’s plan to exempt this device type from the 510(k) requirements. On the other hand, FDA announced its planned partial exemption for genetic health risk assessment systems last November (see our earlier post here). The partial exemption requires manufacturers to obtain 510(k) clearance for their first genetic health risk assessment test, and then all subsequent 510(k)s for tests of this same type are exempt.
According to the Notice, FDA received only one comment regarding the planned exemptions, and it related to need for 510(k) clearance for genetic health risk assessment tests. FDA responded emphatically that its new plan to exempt such tests after a manufacturer obtains clearance for its first such assay will ensure the safety and effectiveness of these assays. FDA’s further documented support for this strategy demonstrates the Agency’s commitment to this plan for certain direct-to-consumer genetic tests. The Notice does not directly address FDA’s authority to regulate laboratory developed tests (LDTs). However, it is inherent in this exemption that FDA firmly believes it has regulatory authority over at least some LDTs. While the partial exemption is not specific to direct-to-consumer LDTs, we anticipate that laboratories will be those who will benefit most from this exemption. We also expect that some laboratories that had been deterred by the prospect of submitting multiple 510(k)s to obtain FDA clearance for multiple tests, may find the 510(k) process more attractive if one submission can effectively result in obtaining clearance for multiple assays.
Finally, the notice also finalized the 510(k) exemption for three other devices: endoscope disinfectant basins, ultraviolet medical water purifiers, and genital vibrators for therapeutic use. Interestingly, this final exemption comes approximately one year after the first final exemption mandated by the 21st Century Cures Act. The Agency is required to issue a new list once every five years thereafter. This publication, however, may be a sign that the Agency will be publishing 510(k) exemption notices more frequently.