Regulation

FDA Final Order: Classification of High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System (Class II)

Citation: 91 FR 63487 (Doc. 2026-20443)
Jurisdiction: U.S.
In force: 2026-10-06
Text: federalregister.gov/documents/2026/10/06/2026-20443/medical-devices-immunology-and-microbiology-devices-classification-of-the-high-throughput-dna
Stories: 1

Healthcare

U.S. FEDRegulation

FDA classifies hereditary cancer DNA sequencing test as class II device

Text (Federal Register) →Oct. 6