Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
fda-device · Food and Drug Administration · Rule · Published 2017-11-07 · Effective 2017-11-07 · 82 FR 51558
Document
Document number
2017-24161
Federal Register citation
82 FR 51558
CFR reference
21 CFR 862
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2017-11-07
Effective date
2017-11-07
HHS docket
Docket No. FDA-2017-N-4394
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system 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 total 25-hydroxyvitamin D mass spectrometry test system'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.