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FDA Draft Guidelines Receive 556 Comments – Thank you to the DOC!

On May 7, the FDA draft guidance for blood glucose monitoring at home and at healthcare facilities FDA draft guidance for blood glucose monitoring - 556 commentsclosed for comment – although that didn’t stop the 556 people from having their voices heard! This represented a notable patient advocacy effort and as a result, the FDA received more than three times the number of comments than on previous diabetes draft guidance documents. Special thanks go to Bennet Dunlap of Strip Safely, and all of the patients who took the time to comment on the FDA guidelines and advocate for policies that keep patients’ best interests at heart. With 30 million people diagnosed with type 1 and type 2 diabetes in the US alone, 556 might sound like a small number – but the growth, one by one, is terrific to see. With so much patient engagement from the diabetes community, we hope the FDA heard the clear call to provide accurate and safe meters (and, more to the point, exclude meters that aren’t accurate), maintain quality and access to diabetes supplies, and to establish postmarket surveillance programs that ensure meters maintain quality following FDA clearance. In regards to the latter, things do seem to be moving in the right direction – the Diabetes Technology Society announced on May 20 that it would initiate just such a program. As we understand it, the Diabetes Technology Society will also be writing more on policy, with a program being established by the very highly regarded Dr. Bruce Quinn – more to follow on that front. The first step is to convene a committee to decide on the program’s specifics. We hope that Bennet is there to represent patients and the patient voices are heard. We’ll be back with more once there is more news to share. –NL/KC

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