Flexibility, Engagement are Covid Lessons for CDRH: Shuren
Regulatory flexibility and developer engagement are two lasting lessons that CDRH has to learn from the Covid-19 emergency, according to director Jeff Shuren. Speaking at an Alliance for a Stronger FDA update 7/22, Shuren said that "these two together were really the drivers of our ability to facilitate the authorization of over 1,500 medical devices for Covid, and they were the secret sauce.”
Reflecting on the early days after the pandemic was declared, Shuren said the Center was able to leverage the emergency use authorization to provide “tremendous flexibility and better tailoring of our evidentiary and other expectations to the technology and then quickly adapt as circumstances change. And that allowed us to facilitate, for example, tests being developed and validated, authorized, and deployed within a few weeks rather than traditional months or a year or longer. And I think that kind of flexibility is something that we need all the time, not just in the setting of the public health emergency.”
Clarifying his remarks, Shuren told the Alliance that he is not talking about changing the U.S. standard of reasonable assurance of safety and effectiveness, which should remain. “What I am talking about is how you meet that standard, and we should have more flexibility in crafting those regulatory pathways to meet that standard and the reason being is we deal with a device regulatory framework that is now essentially 45 years old. It was just fine for literally my grandmother's technology, and it doesn't fit for many of the technologies today like digital health. The stage-gate approach that we have doesn't work for those technologies, and quite frankly they even put patients at risk. We need a modern framework for modern technologies, and the hallmark is this idea of regulatory flexibility.”
Now with developer engagement, Shuren noted the real- or near real-time interactions with product developers during Covid that he wants to continue under the user fee program would provide the necessary resources to make this happen. A proposal has been offered during recent device user fee negotiations called “Total Product Life Cycle Advisory Program (TAP).”
In May, Shuren told an FDA/Xavier MedCon conference what he envisioned with TAP. Currently, he said, CDRH presubmission efforts are under-resourced. “Quite frankly,” Shuren continued, “they're very formal, and you know, there’s a longer timeframe before those formal meetings can happen.” Additional interactions, such as for a breakthrough device, are not well resourced either, he said.
“We have the opportunity to transform the ecosystem, and have a major dent on what goes on across the entire product life cycle,” Shuren said. “And that's what the TAP proposal is about. It is about moving from these more structured formal interactions that we have to more informal interactions, and interactive with you... We want to move more towards having a dialog that can occur, fluid and fast across a variety of products. During the development side, and subsequent to premarket approval or clearance, and to do that, we've kind of put on the table having a cadre of advisors, and a new team of seasoned experts, who can serve as a resource. And they're really [going to be] a liaison out there to developers to answer a lot of basic questions that our lead reviewers just don't have the time to engage on, and secondly to bring together experts across the field.”