Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use
fda-device · Food and Drug Administration · Rule · Published 2017-03-14 · Effective 2017-03-14 · 82 FR 13551
Document
Document number
2017-04941
Federal Register citation
82 FR 13551
CFR reference
21 CFR 862
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-03-14
Effective date
2017-03-14
HHS docket
Docket No. FDA-2017-N-1142
Abstract
The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the high throughput genomic sequence analyzer for clinical use device. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.