Day

December 11, 2018
FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...
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FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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