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

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.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.