# Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
> **Food and Drug Administration** · Final order. · Published 2017-11-07 · Effective 2017-11-07 · 82 FR 51567
## Document
- **Document number:** 2017-24162
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 51567
- **CFR reference:** 21 CFR 866
- **Publication date:** 2017-11-07
- **Effective date:** 2017-11-07
- **HHS docket:** Docket No. FDA-2015-N-3455
## Abstract

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 decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/11/07/2017-24162/medical-devices-exemption-from-premarket-notification-class-ii-devices-autosomal-recessive-carrier)
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