Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System. Final order.

Abstract excerpt

The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will...

Topics

Share this publication in a Topic to start or enrich a Post.

• Share to Genetic Carrier Screening
• Share to Genetic Testing
• Share to Mutation