Alexander Gaffney of raps.org details the Food and Drug Administration’s (FDA) push for new development approaches for diabetes testing systems. FDA has typically not distinguished between prescription and non-prescription diabetes testing devices. In review of the guidance documents, it is clear that FDA wishes to address concerns regarding the potential sharing of devices, as well as cleanliness. To view Gaffney’s article, click here. To help address these concerns, FDA released two new separate draft guidances on January 6, 2014. To see both guidance documents, see the links below:
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
All comments are due April 6, 2014. Need help with your diabetes testing device or diagnostic, contact us at contact@pearlpathways.com.