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

FDA Distinguishes Pre-Market Expectations For Professional Vs. Home Glucose Meters-thegraysheet:  FDA issued two draft guidance documents Jan. 6 providing recommendations that seek to distinguish pre-market submission requirements for blood glucose monitors used in professional health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 by lay users,” the agency said in a federal register notice accompanying the documents.