CLIA related Federal Register and
Code of Federal Regulation Announcements| 9/7/05 | Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability | Text | |||
| 9/15/00 | Medical Devices; CLIA Waiver Criteria; Public Workshop | Text | |||
| 8/14/00 | Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability | Text | |||
| 7/20/00 | Medical Devices; CLIA Waiver Criteria; Public Workshop | Text | |||
| 12/30/99 | 64 FR 73561 |
Transfer of Clinical Laboratory Complexity Categorization Responsibility to CDRH | Text | ||
| 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 | |
| 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 | ||||
| 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 | |
| 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 | |
| 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 | |
| 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 | ||||
| 8/29/97 | HSQ-219-GNC | 62 FR 45815 | CLIA Program; Fee Schedule Revision | Text | |
| 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 | |
| 5/19/97 | HSQ-242-N | 62 FR 27262 | Approval of the Commission on Office Laboratory Accreditation for Immunohematology | Text | |
| 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 | |
| 04/11/97 | 62 FR 17832 | Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity | Text | ||
| 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 | |
| 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 | ||
| 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 | |
| 11/30/95 | HSQ-233-P | 60 FR 61509 | CLIA Programs; Cytology Proficiency Testing | Text | |
| 09/15/95 | HSQ-222-P | 60 FR 47982 | CLIA Program; Categorization and Certification Requirements for a New Subcategory of Moderate Complexity Testing | Text | |
| 09/13/95 | HSQ-225-P | 60 FR 47534 | Public Health Service; CLIA Program; Categorization of Waived Tests | Text | |
| 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 | |
| 07/21/95 | HSQ-229-N | 60 FR 37657 | CLIA Program; Approval of the American Osteopathic Association as an Accrediting Organization | Text | |
| 07/21/95 | HSQ-228-N | 60 FR 37660 | CLIA Program; Approval of the American Association of Blood Banks | Text | |
| 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 | |
| 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 | |
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The items listed below are not available in an electronic format. |
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| 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 December 14, 2005
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