Guidance for Industry and FDA
Staff: Recommendations for Clinical
Laboratory Improvement Amendments of 1988 (CLIA)
Waiver Applications for
Manufacturers of In Vitro
Diagnostic Devices
Document issued on: January 30, 2008
The draft of this guidance document was released on September 7, 2005. For questions regarding this document contact Carol Benson, 240-276-0396 or by email at carol.benson@v
OMB control number:  0910-0598
Expiration Date: 02/28/2010
See additional PRA statement in Section VIII of this guidance
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HF
A-305), Rockville, MD, 20852.  Alternatively, electronic comments may be submitted to v/dockets/ecomments.  When submitting comments, please refer to Docket No. 2008D-0031.  Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet v/cdrh/oivd/guidance/1171.pdf. You may also send an email request to dsmica@v to receive an electronic copy of the guidance, or send a FAX request to 240-276-3151 to receive a hard copy.  Please use the document number 1171 to identify the guidance you are requesting.
TABLE OF CONTENTS
I.INTRODUCTION (5)
The Least Burdensome Approach (7)
II.COMPONENTS OF A CLIA WAIVER APPLICATION (7)
III.DEMONSTRATING "SIMPLE" (8)
IV.DEMONSTRATING "INSIGNIFICANT RISK OF AN ERRONEOUS RESULT" – Failure Alerts and Fail-Safe Mechanisms (9)
A.  Tier 1: Risk Analysis and Flex Studies (11)
B.  Tier 2: Fail-Safe and Failure Alert Mechanisms (13)
1.Points to consider for designing fail-safe and failure alert mechanisms (13)
2.External control materials (14)
3.Additional points concerning control materials (15)
C.  Validating Fail-Safe and Failure Alert Mechanisms, including External Control
Procedures (15)
V. DEMONSTRATING INSIGNIFICANT RISK OF AN  ERRONEOUS RESULT – “ACCURACY” (16)
A.  Clinical Study Sites and Participants (17)
1.Testing sites (17)
2.Clinical study participants (17)
3.Clinical study reports (19)
B.  Clinical Studies for Tests with Quantitative Results (19)
1.Selection of the Comparative Method (CM) (20)
2.Establishing Allowable Total Error Zones and Zones for Erroneous Results
(20)
3.Clinical Study Design (22)
C.  Clinical Studies for Tests with Qualitative Results (26)
1.Selection of the Comparative Method (CM) (26)
2.Clinical Study Design (27)
3.Performance Criteria for Qualitative Tests (31)
VI.LABELING FOR WAIVED DEVICES (32)
A.  Quick Reference Instructions (QRI) (33)
B.  Quality Control (QC) Labeling Recommendations (33)
C.  Educational Information (34)
VII.SAFEGUARDS FOR WAIVED TESTS (35)
VIII.Paperwork Reduction Act of 1995 (35)
REFERENCES (36)
Appendix A: Statistical Notes (38)
alert怎么读Appendix B: Labeling (40)
Appendix C: Definition of Terms as Used in this Document (42)
Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It does not create or confer any rights for, or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
I.INTRODUCTION
The Secretary of Health and Human Services has delegated to FDA the authority to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" under CLIA and thus eligible for waiver categorization (69 FR 22849, April 29, 2004).  The Centers for Medicare & and Medicaid Services (CMS) is responsible for oversight of clinical laboratories, which includes issuing waiver certificates.  CLIA requires that clinical laboratories obtain a certificate before accepting materials derived from the human body for laboratory tests.
42 U.S.C. § 263a(b).  Laboratories that perform only tests that are "simple" and that have an "insignificant risk of an erroneous result" may obtain a certificate of waiver. 42 U.S.C.
§ 263a(d)(2).
CLIA, 42 U.S.C. § 263a(d)(3) Examinations and Procedures, as modified by the Food and Drug Administration Modernization Act (FDAMA), reads as follows regarding tests that may be performed by laboratories with a Certificate of Waiver:
The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an
erroneous result, including those that -- (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the

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