Medical Devices; Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation Test
fda-device · Food and Drug Administration · Rule · Published 2017-11-01 · Effective 2017-11-01 · 82 FR 50530
Document
Document number
2017-23742
Federal Register citation
82 FR 50530
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-11-01
Effective date
2017-11-01
HHS docket
Docket No. FDA-2017-N-5995
Abstract
The Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the BCR-ABL quantitation test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.