Artificial Pancreas Device System: FDA's Role
The FDA is helping advance the development of an artificial pancreas device system by prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, co-sponsoring public forums, and finding ways to shorten study and review time.
Some of these efforts, such as our rapid response to preliminary study plans and interactive review of investigational study plans, are unique to the development of an Artificial Pancreas Device System.
- Rapid Response to Preliminary Study Plans
- Guidance and Standards for Researchers and Industry
- Collaboration with Researchers and Other Stakeholders
- Resources to Expedite Research and Foster Innovation
Rapid Response to Preliminary Study Plans
The FDA's APDS review team responds within two weeks to investigators seeking preliminary feedback on their APDS study plans. This quick, informal feedback helps industry and academic investigators develop better and more complete study plans for FDA review.
Guidance and Standards for Researchers and Industry
FDA guidance and consensus standards help manufacturers and researchers understand the FDA's expectations about how to manufacture a device that is safe and effective. Clear guidance helps them make the best use of resources and streamlines the regulatory review process.
The FDA's Final Guidance for Industry and the Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems outlines flexible recommendations for manufacturers seeking FDA approval to market an artificial pancreas device system. It also encourages greater communication between the FDA and manufacturers and researchers, which will support the rapid, safe and effective development of an Artificial Pancreas Device System. The guidance combines two previously released draft guidances. The FDA combined the two guidances since the issues as well as the comments received by FDA were similar and could be addressed efficiently in a single final document.
The FDA helped develop two standards related to the Artificial Pancreas Device System – a Continuous Glucose Monitoring standard (CLSI POCT05-A) that discusses performance characteristics, and a standard that discusses characteristics of a feedback control system applied to closed-loop control algorithms such as the one used in the artificial pancreas (ISO 60601-1-10).
The FDA issued draft guidance intended to strengthen the safety of infusion pumps, which are one of the three components that make an Artificial Pancreas Device System. See FDA's infusion pump website for more information.
Collaboration with Researchers and Other Stakeholders
Many stakeholders play a role in the development of an Artificial Pancreas Delivery System including diabetes patient groups, diabetes care providers, medical device manufactures, researchers, and academic investigators. The FDA has worked to encourage the collaboration among these groups, so that an Artificial Pancreas Delivery System can be brought to patients more quickly.
The FDA has hosted federal, academic and private researchers, along with diabetes patient advocates, helping put practices in place that facilitate innovation while assuring that safety standards are met.
On July 6-7, 2016, the FDA, the National Institutes of Health (NIH), the Juvenile Diabetes Research Foundation (JDRF), and Helmsley Charitable Trust held a public workshop on the NIH campus. The workshop, "Fourth Artificial Pancreas Workshop: Testing and Adoption of Current and Emerging Technologies" focused on the challenges for the testing of emerging Artificial Pancreas Device Systems and their components. Topics of discussion included integration strategies, clinical testing modalities, psychosocial and usability factors, regulatory and reimbursement consideration.
- On June 2, 2016, the FDA hosted a webinar to share general information about how the FDA regulates diabetes devices and ongoing efforts to accelerate the availability of artificial pancreas devices. The webinar focused on current and emerging artificial pancreas technologies, and the FDA's role in reviewing these technologies for safety and effectiveness.
- On April 9-10, 2013, the FDA, NIH and JDRF held a public workshop on the NIH campus. The "Workshop on Innovation towards an Artificial Pancreas" focused on new technologies that may advance development of an artificial pancreas device system.
- The FDA co-sponsored a public meeting in 2008 with NIH and JDRF and one in 2010 with NIH on the development of an artificial pancreas. At the 2010 meeting both regulators and subject matter experts presented information for product developers to consider. There were also stakeholder-panel discussions where participants discussed potential options for overcoming the challenges of conducting studies and obtaining a marketable product.