Medical Devices; Exemptions From Premarket Notifications; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System; Request for Comments

The Food and Drug Administration (FDA) is announcing its intent to exempt from the premarket notification requirements autosomal recessive carrier screening gene mutation detection systems, subject to certain limitations. These devices are qualitative in vitro molecular diagnostic systems used for genotyping of clinically relevant variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens intended for prescription use or over-the-counter use. These devices are intended for autosomal recessive disease carrier screening in adults of reproductive age. These devices are not intended for copy number variation, cytogenetic, or biochemical testing. FDA is publishing this notice in order to obtain comments regarding the proposed exemption.