Directions on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS)
March 13, 2015 - Temporarily Withdrawn and Reissued as Draft Only- For Comment Only, Draft Additions in RED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.