FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE HIGH THROUGHPUT DNA SEQUENCING FOR HEREDITARY CANCER PREDISPOSITION ASSESSMENT TEST SYSTEM

WASHINGTON, Oct. 6 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System.

The rule was published in the Federal Register on Oct. 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system 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 classification of the high throughpu...