MedCon: Industry praises FDA’s digital health Pre-Cert pilot

Stakeholders in a session at MedCon 2022 expressed largely positive sentiments about their experience with the US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program.

The Pre-Cert program was a pilot program started at FDA because the agency’s “current regulations aren’t optimally suited to the way that digital health technologies are designed, validated, and improved over time,” said Brendan O’Leary, Acting Director of the Digital Health Center of Excellence (DHCoE) within Center for Devices and Radiological Health (CDRH), said in a session at MedCon 2022 based around the program.

“[F]undamentally, in many ways, we have a hardware-oriented regulatory paradigm for devices in this country, and you can see that in the modification frequency that’s assumed in the processes that we have when you juxtapose that with the continuous integration and continuous deployment models that you see for cloud-based software today, ”he said. “You can see that with the limited feedback that we get on products once they’re out the door and how tough it is to get data on those products and their performance in the real world.”

As software continuously changes, the FDA would have difficulty handling regulatory submissions under its current model, O’Leary noted. Changing the model was not only a way to adapt to new technology but also an opportunity “to explore some more agile approaches to regulatory oversight and to advance our mission to protect and promote public health,” he said.

“The vision was really to replace an episodic oversight model with one that’s more continuous, one that better leverages what we can learn about an organization, rather than just about a product, and one that provides improved clarity on product performance to users and FDA, ”O’Leary said.

FDA chose nine companies to participate in the Pre-Cert Program with a goal of a “least-burdensome” total product lifestyle approach to regulatory oversight. The program is focused on organizational excellence represented by five principles with commitments to patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture. These five principals are assessed through an Excellence Appraisal, O’Leary explained.

Feedback from industry

Damien McPhillips, quality director at the Global Software & Digital Health team at Boston Scientific Corporation, said the FDA’s Pre-Cert is a “fabulous program” and noted that regulatory processes keeping pace with digital health innovations is “absolutely necessary.”

“Pre-Cert itself puts the onus on organizations to focus on a culture of quality and organization excellence, and also expects you to commit to monitoring your products and reward performance monitoring,” he said. “The principles themselves focus on product safety and effectiveness, and really, the program itself is a pathway for [a] more faster, iterative release of digital health products. The Pre-Cert framework itself allows for digital health products to be released in a much faster process compared to the current regulatory model. ”

Szymon Perkowski, head of quality at data engineering company BetterOmics, echoed O’Leary’s statement that software does not fit in the current regulatory paradigm. “I strongly believe that the Pre-Cert pilot offers an innovative path forward,” he said.

The program is a faster framework for patients, clinicians, and hospitals for providing “fast and timely” access to Software as a Medical Device (SaMD) products, which improves patient care, he explained. FDA’s Pre-Cert Program also allows industry to quickly make changes to software and “streamlines the existing framework and approach to regulatory clearance.”

There is some overlap in terms of some of the five principles in the program, Perkowski observed. For example, he noted a company that follows the program to achieve excellence in product quality will also implement compliance considerations such as risk management, usability and configuration management. “From a patient safety point of view, this is arguably the most critical pillar in my opinion. This stresses that the company is really demonstrating excellence in providing a safe, patient experience, ”Perkowski said. “It emphasizes that patient safety is a critical factor in the decision-making processes throughout the company, so the patient should really be at the core of decision making.”

There is also a focus on cybersecurity within the five principles, McPhillips observed, which O’Leary agreed was an important element of the program. “[T]he importance of cybersecurity in particular, including as an element of safety, just can’t be overstated, ”O’Leary said. “And when it comes to validation or cybersecurity, I think there can be some real upfront work to be done at the product level, but both of those really underscore how critical it is to keep your eye on the total product lifecycle when you’re thinking about these principles. ”

“[T]he reality is we’re going to be updating these devices, we’re going to need to deploy them in constantly changing technical environments, and so a lot of what Pre-Cert is, it becomes about what expertise, what infrastructure and, yes , what organizational culture and judgment you can build up around that to support that faster modification cycle, ”he said.

Experience with Excellence Appraisals

Both McPhillips and Perkowski praised the positive nature of Excellence Appraisals with the FDA as the agency was assessing organizational excellence. “I know our teams actually themselves were very empowered after the appraisal because they had the opportunity to showcase all the good work they’re doing,” McPhillips said.

Perkowski said the experience at his company was more of a collaborative effort compared with other interactions with the FDA where a quality lead would answer most questions. “This was really a full cross-functional effort where you had teams from usability, engineering, complaints testing,” he said. “Everyone was participating and answering questions with the FDA as opposed to things going through one point of contact.”

O’Leary also discussed his team’s experience on the FDA side when approaching companies for Excellence Appraisals.

“[U]sually when the FDA surprises you, that’s not necessarily considered a good thing. But I think in this case, it really was, ”O’Leary said. “Some of the companies that we engaged with really started out braced for a bit of an inspection or an audit, and that just wasn’t what we were looking to do in this context. Excellence Appraisal is much more of a discussion. So first and foremost, we want to see that you’re engaging the right people at the right time and to the right degree throughout your processes, and we want to talk to those people. ”

Next steps: Congressional action, building out concepts

The FDA is ending the Pre-Cert pilot program, and O’Leary acknowledged that to fully implement the program would require legislation from Congress. “While we’re continuing to develop these concepts and while we’re continuing to apply what we’ve learned in the work that we do today, we’ll have to see where we can take this and what the future looks like going forward. , ”He said.

When asked whether the FDA would revive the pilot program while the agency waits for congressional action, O’Leary said the FDA’s next steps are working with the public-private Medical Device Innovation Consortium (MDIC) and “an even broader group of stakeholders.”

“I think that’s going to be a really tremendous opportunity to continue to explore some of these concepts, to build them out, to pressure test them with a more heterogeneous group of organizations, and to really figure out how we can design something that can scale here, ”he said.

© 2022 Regulatory Affairs Professionals Society.

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