FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE INHERITED NUCLEOTIDE REPEAT DISORDER DEOXYRIBONUCLEIC ACID TEST

WASHINGTON, May 29 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test.

The rule was published in the Federal Register on May 29 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is classifying the inherited nucleotide repeat disorder DNA test 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 inherited nucleotide repeat disorder DNA test's classification. We are taking this action...