Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device

Information

Type

Rule

Regulated products

Medical Devices

Published

September 11, 2024

Last updated

September 11, 2024

Description

Document number 2024-20550. 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.

Organization

Country / Region

United States

License

Other (Public Domain)

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