ABOUT GUIDANCE / Learn about the Drafts

Related Pages at StripSafely
Draft Comments
How to Comment
Comments on third party strips.

FDA’s Guidance Documents:

Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf

Blood Glucose Monitoring Test Systems for Prescription Point-of- Care Use

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf

Social Media Resources:

Setting the Bar for Blood Glucose Meter Performance

FDAVoice | Courtney Lias | January 9, 2014
http://blogs.fda.gov/fdavoice/index.php/2014/01/setting-the-bar-for-blood-glucose-meter-performance/#sthash.Pvm2Kb97.dpuf

 

Interview with Bennet Dunlap: D-Advocacy and the FDA

tuDiabetes | Emily Coles | February 28, 2014 

FDA’S New Draft Guidance on Blood Glucose Test Strips

ASweetLife | Catherine Price | January 23, 2014
http://asweetlife.org/feature/fdas-new-guidance-on-blood-glucose-test-strips 

 

Fighting for Better Test Strips

Insulin Nation | Courtney Naliboff | February 28th, 2014

http://insulinnation.com/treatment2/fighting-for-better-test-strips/

 

Glucose Meter Accuracy: FDA’s New Dual Call for Tighter Standards

DiabetesMine | Amy Tenderich | January 22, 2014
http://www.diabetesmine.com/2014/01/glucose-meter-accuracy-fdas-new-dual-call-for-tighter-standards.html

Moving to Better Meter Accuracy

dLife | Bennet Dunlap | January 2014
http://www.dlife.com/diabetes/blood_sugar_management/testing/bennet_dunlap/better_meter_accuracy