Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens
fda-device · Food and Drug Administration · Rule · Published 2014-05-30 · Effective 2014-06-30 · 79 FR 31023
Document
Document number
2014-12544
Federal Register citation
79 FR 31023
CFR reference
21 CFR 866
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-05-30
Effective date
2014-06-30
HHS docket
Docket No. FDA-2013-N-0544
Abstract
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled "Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens." These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.