Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
fda-device · Food and Drug Administration · Rule · Published 2017-12-27 · Effective 2017-12-27 · 82 FR 61162
Document
Document number
2017-27853
Federal Register citation
82 FR 61162
CFR reference
21 CFR 862
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-12-27
Effective date
2017-12-27
HHS docket
Docket No. FDA-2017-N-6593
Abstract
The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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.