2024-20896. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers

Table 1—Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers Risks and Mitigation Measures

Identified risks to health	Mitigation measures
False test results	Use of certain specimen collection and transport devices; Certain labeling information; and Certain design verification and validation.
Failure to correctly interpret the test results	Certain labeling information.