Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays
fda-device · Food and Drug Administration · Rule · Published 2017-07-27 · Effective 2017-07-27 · 82 FR 34848
Document
Document number
2017-15858
Federal Register citation
82 FR 34848
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-07-27
Effective date
2017-07-27
HHS docket
Docket No. FDA-2017-N-1917
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays 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 assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.