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FDA Distinguishes Pre-Market Expectations For Professional Vs. Home Glucose Meters

The agency for the first time issued distinct guidance documents for blood glucose meters used in professional settings and those issued over-the-counter for self-monitoring tests by lay-persons. FDA is collecting comments on draft versions of the guidelines.

FDA issued two draft guidance documents Jan. 6 providing recommendations that seek to distinguish pre-market submission requirements for blood glucose monitors used in professional health care settings versus over-the-counter self-monitoring by lay-persons.

“Historically, FDA has not recommended different types of information in pre-market submissions (510(k)s) for blood glucose monitoring systems used by medical professionals as compared to [over-the-counter] devices intended for use...

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