Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System
fda-device · Food and Drug Administration · Rule · Published 2015-10-27 · Effective 2015-10-27 · 80 FR 65626
Document
Document number
2015-27197
Federal Register citation
80 FR 65626
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-10-27
Effective date
2015-10-27
HHS docket
Docket No. FDA-2015-N-3472
Abstract
The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.