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Title
Directions on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS)
Memo #
15-11-CLIA
Posting Date
2014-11-21
Fiscal Year
2015
Summary
March 13, 2015 - Temporarily Withdrawn and Reissued as Draft Only- For Comment Only, Draft Additions in RED • “Off-Label Use” of BGMS: Using a test outside of its Food and Drug Administration (FDA)-approved/-cleared intended use, limitations or precautions, as indicated in the manufacturer’s instructions, is considered “off-label use.” “Off-label use” applies whether the test is waived or non-waived and it means that the test is considered modified and therefore defaults to a high-complexity test under the Clinical Laboratory Improvement Amendments (CLIA) regulations. This will require all laboratories using the device for an “off label use” to meet all applicable CLIA high-complexity requirements. • Surveyors Will Document Off-Label Use: If any non-compliance is identified, a written statement of deficiencies (Form CMS-2567) will be issued and followed up using standard operating procedures and timeframes found in the applicable regulations and guidance documents. • Frequently Asked Questions (FAQs): Included with this memorandum are FAQs prepared by Centers for Medicare & Medicaid Services (CMS) and FAQs prepared by the FDA, respectively that provide responses to key questions.
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