Praise for FDA's new pilot, TEMPO

My mission is to accelerate the innovation of great technology for people who need it. TEMPO is a great opportunity for acceleration.

What if a device manufacturer could propose to the FDA that their device is relatively low-risk, and the only way to affordably determine efficacy is to bring it to market and measure real-world outcomes? Well, now it seems they can. The FDA is welcoming applicants to the TEMPO pilot to evaluate the feasibility of doing just that, specifically for digital health devices intended for chronic disease. 

The U.S. regulatory environment has needed this for a long while.  

In 2021 my team launched a project with CDRH to accelerate decision-making for low-risk, unknown-benefit de novo devices, while preserving or increasing the decision quality. It was clear that the “right” solution, if we were unconstrained by norms and statute, would be to allow the devices on the market, see what happens, measure customer (aka patient) feedback, and then assess the device. Basically, allow the device to act like an unreglated consumer device. 

There are myriad problems with this approach that I won’t delve into, but I’ll just mention here: how would FDA signal to consumers that the level of trust in these devices is not yet the same as those with normal clearance? How would CMS consider these devices in coverage? How would the postmarket data be collected, especially before UDI is implemented? These were important questions that didn’t have answers, and we didn’t look into it because it wasn’t our remit at the time. 

During the project, we focused on all de novos, not just digital health. In digital health, there is a much higher likelihood that the manufacturer can measure outcomes and report them to the FDA. And now, FDA is testing this with TEMPO. 

TEMPO sounds like a rebirth of the Pre-Cert Pilot

When I was designing the project mentioned above, CDRH leaders warned me not to call it a “pilot.” The word “piot” elicits groans across the FDA centers. Maybe this administration didn’t get the memo, but sometimes you have to call a spade a spade. 

The Pre-Cert Pilot was an effort to create a pathway unique to digital health devices. The idea was to fast-track the device onto the market provided the manufacturer could prove that its quality system was strong. (I’m oversimplifying this, bear with me.) Now, instead of pre-qualifying the organization, TEMPO proposes to say, “Okay, manufacturer, you can sink or swim on your own merit.” I love this. Obviously, the devil is in the details for implementation. But what I love about this one is that patients aka customers aka device users are inherently in the mix. In Pre-Cert, FDA and organizations decided what was “safe enough” to go to market faster. In TEMPO, the success of the device will be driven by the outcomes for its customers and users. 

In TEMPO, the success of the device will be driven by the outcomes for its customers and users.

TEMPO is ideal for Automated Insulin Delivery Manufacturers

TEMPO can only be as successful as the outcomes are observable by the users of the device. Chronic diseases are a class that inherently include this situation. People with chronic diseases are suffering from daily symptoms or burdens that they can perceive (e.g., people with type 1 diabetes can perceive when their blood sugar is low or high, people with migraines can perceive when they have or are going to get a migraine). I can only assume that FDA will only allow devices for which serious consequences (e.g., diabetic retinopathy) won’t go unnoticed. In any case, diabetes manufacturers, I hope you’re taking note. Loopers, you too! 

Three cheers for TEMPO. I hope this pilot goes as well as it can! 

~Shannon, the Optimistic Optimizer