Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression
fda-device · Food and Drug Administration · Rule · Published 2023-01-17 · Effective 2023-01-17 · 88 FR 2518
Document
Document number
2023-00480
Federal Register citation
88 FR 2518
CFR reference
21 CFR 862
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2023-01-17
Effective date
2023-01-17
HHS docket
Docket No. FDA-2022-N-3335
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression 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 prognostic test for assessment of liver related disease progression'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.