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Reissuance of S&C 15-11 As DRAFT ONLY – FOR COMMENT Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS)
Guidance for “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.”
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: March 13, 2015
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