Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
fda-device · Food and Drug Administration · Rule · Published 2024-09-23 · Effective 2024-10-23 · 89 FR 77448
Document
Document number
2024-21616
Federal Register citation
89 FR 77448
CFR reference
21 CFR 866
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-23
Effective date
2024-10-23
HHS docket
Docket No. FDA-2016-N-2880
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.