Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
fda-device · Food and Drug Administration · Rule · Published 2024-09-11 · Effective 2024-09-11 · 89 FR 73565
Document
Document number
2024-20550
Federal Register citation
89 FR 73565
CFR reference
21 CFR 866
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2024-09-11
Effective date
2024-09-11
HHS docket
Docket No. FDA-2024-N-4018
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the whole exome sequencing constituent device 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 whole exome sequencing constituent device'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.