We were so pleased to host two key individuals from the FDA at this year's DiabetesMine Innovation Summit: Courtney Lias, Director of CDRH/Division of Chemistry and Toxicology (who gave one of the opening talks updating us on FDA progress), and her colleague Stayce Beck, head of the FDA's artificial pancreas team. Their involvement in this patient-led leadership forum is proof that the ePatient Revolution is changing the dynamics of health and medicine policy!

Today, these two leaders share their thoughts on the event, milestones their agency has accomplished in 2013, and the biggest FDA-diabetes challenges for 2014:


A Guest Post by Stayce Beck & Courtney Lias of FDA

Once again, FDA had the privilege of attending the 2013 DiabetesMine Innovation Summit this past November. This was another great opportunity for us to share current FDA regulatory perspectives with the diabetes community and to update attendees on many of FDA's ongoing efforts related to diabetes. Even more importantly, it gave us a chance to interact with the diabetes community and hear some of the trials and tribulations that people living with diabetes and working in the field encounter. This allows us to better recognize how the work that we do can affect the diabetes community, and helps us to better tailor our efforts to make the most impact.

People living with diabetes face acute risks every day due to hyper- and hypoglycemia, as well as long-term chronic health impacts. Safe, simple, effective products for diabetes control and monitoring are a necessity to improve the quality of life for people battling this serious chronic disease. Over the last few years, FDA's Center for Devices and Radiological Health (CDRH), recognized room for improvement in our regulatory processes related to diabetes devices and worked to implement these processes both before and after new products enter the market.

Recently, FDA released two draft guidance documents for blood glucose meters:

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

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

These two guidance documents outline separate criteria that FDA recommends for the design and evaluation of blood glucose meters based on the population that is intended to use them (those used lay-persons at home for self-monitoring vs. those used in health care facilities), to help manufacturers better tailor their device for the appropriate population.

Highlights of these guidance documents include tightened accuracy criteria for the meters, particularly in the hypoglycemic range; and that labeling on the outside of the box display the accuracy of the device so that users can make informed decisions before purchasing new meters.

In addition, the guidances propose that the FDA review manufacturer's test strip lot release criteria, which should help prevent the release of less accurate test strips onto the market. The proposed recommendations made in these draft guidances can help ensure that users have access to meters that meet critical standards for accuracy and will limit complications related to blood glucose meters. We hope that with the release of these draft guidance documents, FDA can help encourage advances that will result in improved accuracy for all meters while still keeping costs reasonable. We encourage you to provide specific comments about what you agree with in the documents and where you see room for improvement. We are eager to get your thoughts and improve them based on your feedback.

{Editor's Note: click here for our coverage of the FDA guidances & links for commenting}

A lot of concerns have been raised about the quality of blood glucose meters and test strips after they have been cleared for use in the market and the FDA has been focusing our efforts in this post-market arena as well. The FDA receives more than 25,000 reports of device malfunctions or injuries per year for glucose meters. This extremely high number can be very challenging to interpret, both because of the high volume as well as the low quality of data contained in these reports. Therefore, we are working to develop new methods to analyze these reports and to provide guidance to manufacturers on reporting criteria to help improve consistency across manufacturers. Finally, we are working together with the Diabetes Technology Society (DTS) and patient advocacy groups to draft a possible surveillance program that we hope will help to ensure that consistent quality products are released on the market and to improve safety.

In addition to our efforts to improve safety and accuracy of blood glucose meters, we are very excited that we were able to approve two new Continuous Glucose Monitors (CGMs), the Dexcom G4 Platinum and Medtronic Enlite. Both of these sensors exhibited improved accuracy compared to their respective predecessors (Dexcom Seven Plus and Medtronic Sof-sensor). Another novel advance this past year was the approval of the Medtronic 530G, the first FDA-approved threshold suspend system. We look forward to working with manufactures to see more advances for sensors and artificial pancreas systems in the future.

While we are encouraged by the successes of 2013, several outstanding challenges for both artificial pancreas systems as well as daily management of diabetes with traditional devices remain. The inability of different devices to communicate with each other, also known as interoperability, can lead to a lot of frustration for users. Many groups are working on several fronts including consolidation of software so that information from all of the devices can be viewed at once, remote data uploading, mobile medical applications for diabetes, and standardization of data formats so that users can easily interpret the data and use it effectively to manage their diabetes. The guidance on mobile medical applications that was finalized in 2013 provides more information and clarity about FDA's thinking on this topic and we look forward to working together to address interoperability challenges.

While we understand that the regulatory process is still not perfect, we have tried to focus our efforts this past year on improving the review process and facilitating more choices for diabetes management. The Innovation Summit was a great opportunity for FDA to learn from people affected by diabetes and to interact with manufacturers to improve the review process and help get some of these innovations out to patients. We look forward to working together as a community and are always looking for new ways to connect and ensure that all voices are heard.


Thank you, forward-thinking FDA folks! Our community looks forward to more open communication and positive progress this year!

Disclaimer: Content created by the Diabetes Mine team. For more details click here.


This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.