The FDA is helping advance the development of an artificial pancreas device system (APDS) 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 APDS.
- Rapid Response to Preliminary Study Plans
- Interactive Review of Investigational Device Exemption (IDE) Study Plans
- Guidance and Standards for Researchers and Industry
- Collaboration with Researchers and Other Stakeholders
- Resources to Expedite Research and Foster Innovation
The FDA’s APDS review team responds within two weeks to investigators seeking preliminary feedback on their APDS study plans. This quick, informal feedback can help investigators develop better and more complete study plans for FDA review.
When investigators submit their final study plans for FDA review, the APDS review team gives these submissions the highest priority and works interactively with investigators to move them quickly and efficiently through the review process. Questions and research challenges are resolved during the first round of review, helping researchers start their studies sooner.
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.
In October 2012 the FDA issued 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. This guidance outlines flexible recommendations for how manufacturers seeking to market an artificial pancreas device system can demonstrate safety and effectiveness to receive device approval. It also promotes greater communication between the FDA and manufacturers and researchers, which will support the rapid, safe and effective development of an APDS. 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 APDS – 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 APDS. See FDA's infusion pump website for more information.
Many stakeholders play a role in the development of an APDS—researchers, clinicians, medical device designers and manufacturers. The FDA has worked to encourage the collaboration among these groups, so that an APDS can be brought to patients more quickly.
The FDA has hosted federal, academic and private researchers, along with diabetes patient advocates, to help put practices in place that facilitate innovation while assuring that safety standards are met. The FDA co-sponsored a public meeting in 2008 with NIH and JDRF and one in 2010 meeting 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.
At these and other venues the FDA has shared with researchers and other stakeholders knowledge from the agency’s pre- and post-market reviews of the components of an APDS—continuous glucose monitoring systems and insulin infusion pumps. This enables those working on APDSs to better understand the challenges of combining the component devices into a new, more comprehensive system.
On April 9-10, 2013, the FDA, the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (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. Meeting information and registration can be found at http://www2.niddk.nih.gov/News/Calendar/Pancreas2013.htm
Providing researchers with access to innovative tools and key information can help save time and resources and foster innovation.
In silico modeling
The FDA led a team of scientists and clinicians to review the scientific validity of an in-silico model – a computer program developed by an artificial pancreas researcher that simulates the daily glucose changes of different patients with type 1 diabetes. The model enables researchers to quickly test artificial pancreas control algorithms and is accepted in place of costly and time-consuming animal studies that precede human clinical trials.
The FDA worked with the developer of this program so that researchers working on an APDS could test control algorithms and use the results in support of regulatory submissions. As a result, there are now hundreds of theoretical, FDA-accepted patient models that other researchers can use to test control algorithms. The FDA also welcomes the submission of alternative in silico models for evaluation.
Information from approved products
A Master File (MAF) is a repository of confidential or trade secret information that, upon authorization by the MAF holder, the FDA can reference in support of another submission. To better share information available to the FDA on the existing medical devices that are components of the APDS—continuous glucose monitoring systems, blood glucose devices, and insulin infusion pumps—the FDA worked with industry to provide certain researchers with information about specific devices from these files that may help their research.