CLIA related Federal Register and Code of Federal Regulation Announcements

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CLIA related Federal Register and
Code of Federal Regulation Announcements

9/15/00			Medical Devices; CLIA Waiver Criteria; Public Workshop	Text	PDF
8/14/00			Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability	Text	PDF
7/20/00			Medical Devices; CLIA Waiver Criteria; Public Workshop	Text	PDF
12/30/99		64 FR 73561	Transfer of Clinical Laboratory Complexity Categorization Responsibility to CDRH	Text	PDF
10/14/98	HCFA-2024-FC	63 FR 55031	Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Lab Requirements Under CLIA	Text	PDF
Code of Federal Regulations (10/98) Part 493 Laboratory Requirements This document contains the codified CLIA regulations as of October 1, 1998 and includes the documents denoted with -F, -FC or -CN (listed below).				Text	PDF
6/15/98	HCFA-2239-F (Corrections)	63 FR 26722	CLIA Program; Simplifying CLIA Regulations Relating to Accreditation, Exemption of Laboratories Under a State Licensure Program, Proficiency Testing, and Inspection	Text	PDF
5/14/98	HCFA-2239-F	63 FR 26722	CLIA Program; Simplifying CLIA Regulations Relating to Accreditation, Exemption of Laboratories Under a State Licensure Program, Proficiency Testing, and Inspection	Text	PDF
4/9/98	HCFA-2246-N	63 FR 17429	Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Approval as an Accrediting Organization: Joint Commission on the Accreditation of Healthcare Organizations (JCAHO); American Association of Blood Banks (AABB); and American Osteopathic Association (AOA)	Text	PDF
Code of Federal Regulations (10/97) Part 493 Laboratory Requirements This document contains the codified CLIA regulations as of October 1997 and includes the documents denoted with -F, -FC or -CN (listed below).				Text	PDF
8/29/97	HSQ-219-GNC	62 FR 45815	CLIA Program; Fee Schedule Revision	Text	PDF
7/1/97	HSQ-243-N	62 FR 35513	Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Exemption of Laboratories Licensed by the State of Washington	Text	PDF
5/19/97	HSQ-242-N	62 FR 27262	Approval of the Commission on Office Laboratory Accreditation for Immunohematology	Text	PDF
5/12/97	HSQ-237-FC	62 FR 25855	Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Requirements--Extension of Certain Effective Dates for Clinical Laboratory Requirements under CLIA	Text	PDF
04/11/97		62 FR 17832	Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity	Text	PDF
02/05/97	HSQ-244-N	62 FR 5433	CLIA Program; Clinical Laboratory Improvement Amendments of 1988 - Denial of Exemption of Laboratories in the Commonwealth of Puerto Rico	Text	PDF
07/08/96		61 FR 35736	Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity; Notice of Additional Waived Laboratory Test Systems, Assays, and Examinations; and Notice of Announcement of Boards Approved by HHS	Text	PDF
06/13/96	HSQ-231-N	61 FR 30072	Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories in the State of Oregon	Text	PDF
11/30/95	HSQ-233-P	60 FR 61509	CLIA Programs; Cytology Proficiency Testing	Text	PDF
09/15/95	HSQ-222-P	60 FR 47982	CLIA Program; Categorization and Certification Requirements for a New Subcategory of Moderate Complexity Testing	Text	PDF
09/13/95	HSQ-225-P	60 FR 47534	Public Health Service; CLIA Program; Categorization of Waived Tests	Text	PDF
08/28/95	HSQ-230-N	60 FR 44503	Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York	Text	PDF
07/21/95	HSQ-229-N	60 FR 37657	CLIA Program; Approval of the American Osteopathic Association as an Accrediting Organization	Text	PDF
07/21/95	HSQ-228-N	60 FR 37660	CLIA Program; Approval of the American Association of Blood Banks	Text	PDF
05/15/95		60 FR 25944	Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity	Text
02/09/95	HSQ-223-N	60 FR 7774	CLIA Program; Approval of the College of American Pathologists	Text	PDF
01/03/95	HSQ-224-N	60 FR 130	CLIA Program: Approval of the Joint Commission on Accreditation of Healthcare Organizations as an Accrediting Organization	Text
12/23/94	HSQ-221-N	59 FR 66314	Medicare, Medicaid and CLIA Programs; Clinical Laboratory Amendments of 1988 Continuance of Exemption of Laboratories Licensed by the State of Washington	Text
12/06/94	HSQ-217-FC	59 FR 233	Medicare, Medicaid and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for Cytologists	Text
10/20/94	HSQ-220-N	59 FR 52968	CLIA Program; Approval of the American Society for Histocompatibility and Immunogenetics (ASHI) for the Specialty of Histocompatibility	Text
01/06/94	HSQ-210-FC	59 FR 682	Medicare, Medicaid and CLIA Programs; Personnel Requirements for Cytotechnologists	Text
The items listed below are not available in an electronic format.
12/23/93	HSQ-211-N	58 FR 68148	Approval of the Commission on Office Laboratory Accreditation (COLA)
10/6/93	HSQ-209-N	58 FR 52115	Medicare, Medicaid and CLIA Programs: CLIA '88 Exemption of Laboratories Licensed by the State of Washington
07/26/93		58 FR 39860	Compiled List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity
07/22/93	HSQ-202-CN	58 FR 39154	Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988
01/19/93	HSQ-206-F	58 FR 5212	Medicare, Medicaid and CLIA Programs; CLIA Program Fee Collection; Correction
01/19/93	HSQ-202-FC	58 FR 5215	Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Improvement Act Program Fee Collection
10/01/92		57 FR 45392	Deletion of text from previously published notice
09/02/92		57 FR 40239	Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity, Notice
08/28/92		57 FR 39211	Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity
08/11/92	HSQ-176-CN	57 FR 35760	Medicare Program; Medicare and Laboratory Certification Program; Enforcement Procedures for Laboratories
07/31/92	HSQ-181-F	57 FR 33992	Clinical Laboratories Improvement Program; Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and or CLIA Exemptions Under State Laboratory Programs
07/08/92		57 FR 30362	Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity
02/28/92		57 FR 7245	Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity
02/28/92	HSQ-179-F	57 FR 7218	Medicare Program, Medicare and Laboratory Certification Program; Enforcement Procedures for Laboratories
02/28/92	HSQ-177-FC	57 FR 7188	Clinical Laboratory Improvement Act Program; Fee Collection
02/28/92	HSQ-176-FC	57 FR 7002	Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
04/02/91	HSQ-179-P	56 FR 13430	Medicare and Laboratory Certification Programs; Enforcement Procedures for Laboratories
08/20/90	HSQ-146-CN	55 FR 33907	Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs; correction
08/20/90	HSQ-181-P	55 FR 33936	Clinical Laboratory Improvement Act Program; Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and State Licensure Agencies
08/03/90	HSQ-177-P	55 FR 31758	Clinical Laboratory Improvement Act Programs; Fee Collection
05/21/90	HSQ-176-P	55 FR 20896	Medicare, Medicaid and CLIA Programs: Regulations Implementing the Clinical Laboratory Improvements of 1988 (CLIA '88)
03/14/90	HSQ-146-F	55 FR 9538	Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratory Improvement Act of 1967 Programs
10/31/88	P.L. 100-578	Public Law	CLIA '88
09/29/88	S.R. 100-561	Senate Report	Medical Testing Improvement Act of 1988
09/09/88	H.R. 100-899	House Report	Clinical Laboratory Improvement Amendments of 1988
08/05/88	HSQ-146-P	53 FR 29590	Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs

Updated 9/27/2000

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Center for Devices and Radiological Health / CDRH