FDA Proposes Accelerated Access to Medical Devices – A Faster Path to the Artificial Pancreas?

On April 22, the FDA announced an exciting new program to accelerate access to medical devices that address major unmet needs. This should mean earlier and more interactive discussions with FDA representatives, a collaborative plan with companies to ensure that review/approval goes more smoothly and predictably, fewer requirements needed before launch, and a faster review. (Close your eyes and say all that – it does sound too good to be true, doesn’t it!) It’s exciting to hear this new FDA effort to increase the speed of medical device reviews and approvals. While Europe has consistently seen new devices reach market before the US (e.g., the Animas Vibe, the Medtronic Veo/MiniMed 530G), we think things are slowing down there, in some cases, appropriately so – so it’s notable that, at least theoretically, the result of policy shifts on both sides of the water should ultimately result in timelines being more similar.

Notably, it’s believed that the new expedited program could apply to artificial pancreas systems currently in development. Indeed, devices that qualify for the program must treat a life-threatening or chronic condition, represent a significant advantage for patients, and have a data development plan approved by the FDA. Certainly, artificial pancreas systems could be transformative for patients, and the new program seems to fit well with a fully automated overnight closed-loop system that also incorporates some daytime automation (e.g., “control to range” that minimizes hypo- and hyperglycemia). It’s still unclear which devices will fit the new program’s guidelines – for instance, will predictive low glucose suspend count – but the FDA will likely decide on a case-by-case basis. This news continues a very positive recent trend of more interactive dialogue and patient-friendliness from the FDA. –NL/AB