FDA Takes Unconventionally Hands-On Role to Approve New Technology 
​​[Posted on: Thursday, December 7, 2017]

This week FDA described its heavily hands-on approach for the approval of “Artificial Pancreas” to highlight how FDA reviewers could play an active role in approval of innovative new products. There are several lessons for other developers in this story and notes of caution as well. The automated insulin dosing system, commonly known as an “artificial pancreas” device is a combination of three previously FDA-approved technologies. It uses an insulin pump, connected to an interactive blood glucose monitor which, in turn, uses an algorithm that determines the needed insulin dose based on blood sugar levels and other considerations, and then transmits that information to the insulin pump for releasing the right amount of insulin without need for human intervention. Insulin pumps, interactive glucose monitors and calculating algorithms had all been previously approved by FDA. But combining these three to create a truly automated insulin delivery system raised new concerns. FDA was aware of the concerns among patient populations regarding the regulatory challenges with approval of artificial pancreas medical devices thanks to its patient interactions. So, it created an “Artificial Pancreas Team” that interacted with patients and caregivers to better understand the need. The artificial pancreas team identified academic investigators and device developers involved in creating such devices and provided unfettered access to them to directly approach for any questions regarding the device design, clinical trials and other issues. FDA reviewers met the developers practically every month for three years to help design the device, its testing methods, and the clinical program that relied on a small, focused clinical trial to support approval of the device, and a larger post-market commitment to gather additional real-world information about use of the device, ultimately resulting in market approval of the device about three years ahead of schedule and with lesser work and cost. The first key lesson from this story is that for developing new innovative products with clear and defined patient need, do not assume what FDA would want. The conventional thought may lead to incorrect assumptions about the cost, time, and acceptable data for approval. It is critical that developers communicate with FDA early and frequently thereafter to involve the FDA reviewers in all aspects of product development. Second, involve patients who can directly educate FDA reviewers about the patient’s perspectives of the need for a given product, the perception of acceptable risk, and help FDA reviewers adjust data requirements appropriately to meet patient need. Third, such interactions are likely more feasible for the first product of each kind. Once the first product is released in the market, likely FDA teams will wait to see the real world evidence of the use of the approved device to figure the next area of interest. Developers of me-too devices should not expect similar extensive interactions as the first developer. Fourth, this trend of FDA’s hands-on approach is not limited to medical devices only; all Centers at FDA have similar programs. And this is also not the first time FDA reviewers have gone out of their way to help innovative products to the patient. So, all developers should consider all options to build a robust and highly interactive relationship with FDA reviewers.