2024-20550. Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device

Table 1—Whole Exome Sequencing Constituent Device Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Inaccurate test results and failure to provide results	Certain design verification and validation, including certain analytical studies and clinical studies; and Certain labeling information, including certain performance information and device limitations.
Incorrect application or interpretation of results	Certain design verification and validation, including certain clinical studies; and Certain labeling information, including certain performance information and device limitations.
User error and improper use of the device	Certain design verification and validation, including certain analytical studies and clinical studies; and Certain labeling information, including certain performance information and device limitations.