Responding to patient criticism about how long CDRH takes to review and approve new diabetes technology, three Center officials have taken an unprecedented approach by providing a guest post on a patient blog. The officials—CDRH office of in vitro diagnostics director Alberto Gutierrez, biomedical engineer Stayce Beck, and device reviewer Arleen Pinkos—had earlier presented at a diabetes conference at Stanford University where patient concerns were heard, and their post was a summary of the “takeaways” from the event.
“We understand the kind of burden that diabetes management presents to patients and we weren’t completely surprised to hear the community voice concern over the length of time it takes us to review and approve new, innovative diabetes technology,” their guest post said. “Central to this conversation was the need for researchers, manufacturers and the FDA to work closely and collaboratively in the earliest possible stages of device development. For it is in the early stages that we can all best think creatively about what kind of studies and data will be necessary to support the successful approval of new technology in the shortest timeframe.”
The CDRH officials said the Center is exploring other ways to expedite innovative device development of new and innovative devices. For example, a recent guidance provides development recommendations for an artificial pancreas. And the Center has “consolidated the artificial pancreas review under a single management chain reducing internal inconsistencies and providing clearer priorities for that team,” they said. “FDA’s recent quick approval of a new continuous glucose monitor sensor, the Dexcom G4 sensor, and approval of the first outpatient studies of an artificial pancreas device are both positive examples of FDA’s efforts to expedite the device development process.”
The post also touched on a policy being developed for mobile medical apps for smartphones and tablets that likely will impact diabetes management. “By working with a wide range of groups, the FDA is developing a policy for mobile medical apps that will assure that those apps that present the greatest patient risk receive the appropriate agency review,” they wrote. “We want to make sure that our regulation is as smart and as nimble as the technology it is designed to cover.”
Additionally, CDRH plans to work more closely with patient groups, according to the officials. “Directly connecting to the patient community—and not just those with diabetes—helps us better accomplish our public health mission. To that end, you will be hearing from us and hopefully see us more often.”
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