Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Laboratory Techniques -- standards Diagnostic Errors Reagent Kits, Diagnostic -- standards United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- 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 the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and are thus eligible for waiver categorization (69 FR 22849, April 29, 2004). The Centers for Medicare & Medicaid Services (CMS) is responsible for oversight of clinical laboratories, which includes issuing waiver certificates. CLIA requires that clinical laboratories obtain a certificate before testing materials derived from the human body. Laboratories that perform only tests that are "simple" and that have an "insignificant risk of an erroneous result" may obtain a Certificate of Waiver. Section 263a(d)(3) of CLIA, 42 U.S.C. subsection 263a(d)(3), Examinations and Procedures, as modified by the Food and Drug Administration Modernization Act (FDAMA), states the following 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 Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly. This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver described above.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (29 pages)).
- NLM Unique ID:
- 101772617 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772617