Notice of specific list for categorization of laboratory test systems, assays, and examinations by complexity--CDC. Notice with comment period
Federal Register 62(70): 17832-17849
1997
ISSN/ISBN: 0097-6326 PMID: 10172993 Document Number: 382343
Regulations codified at 42 CFR 493.17, implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, require that the Secretary provide for the categorization of specific laboratory test systems, assays, and examinations by level of complexity. The criteria for such categorizations also are set forth in those regulations. This Notice announces the addition of approximately 1,300 test systems, assays, and examinations that have been categorized and notified between June 7, 1996 and December 31, 1996. These categorizations were effective on the issue date of the notification letter sent to the manufacturer and are subject to the 30 day comment period for this Notice.