Compliance, Regulatory & Quality Consultants

A “laboratory” or “clinical laboratory” means any facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body to provide information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

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The Secretary of Health and Human Services has delegated to the 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:

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CFR Compliance LLC™ assists clients and laboratories with laboratory requirements as established by Section 263a(d)(3) of CLIA and 42 U.S.C. § 263a(d)(3). Some of our services:

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• CLIA Waiver Applications

• Risk Analysis and Flex Studies

• Fail-Safe and Failure Alert Mechanisms

• External Control Procedures

• Study Design Options

• Considerations in Satisfying CLIA Waiver Requirements

• Testing sites (Operators and Patients)

• Specimen Collection and Sample Preparation

• Financial disclosures

• Clinical study reports

• Labeling for Waived Devices

• Quality Control (QC) Labeling Recommendations

• Safeguards for Waived Tests

• Training