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Medical Devices / Regulatory Affairs

FDA Releases Draft Guidances on Blood Glucose Monitors

Dec. 4, 2018
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The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the agency issued in 2016.

The guidances were revised based on “additional feedback from stakeholders requesting more clarification on design considerations and recommended standards,” the agency said.

The revised drafts include recommendations for what to include in 510(k) submissions, as well as suggestions for performance studies.

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