CDRH’s Outgoing Digital Health Chief: Pre-Cert Needs New Legislative Authority


Bakul Patel, former head of digital health at the US Food and Drug Administration (FDA), said he always knew the agency needed additional authority from Congress to fully implement a new digital health product pathway in an interview with Focus on Sunday.

On April 30, Patel, longtime director of digital health for the FDA’s Center for Devices and Radiological Health (CDRH), announced the LinkedIn that he was leaving the agency after more than 13 years.

“It’s truly been an incredible journey since 2008, from introducing the concept of ‘feature-based regulations’ in the agency’s guidelines on mobile medical apps…to working with international regulators to coin the term [software as a medical device (SaMD] to develop [FDA’s precertification (Pre-Cert) program]…to finally launch the Center of Excellence in Digital Health,” he said. wrote.

New authorities

“We knew going into the Pre-Cert concept that we wouldn’t be able to do it under our current authorities,” Patel said. Focus. “If you look at the documents that we released earlier, we basically said, ‘Look, we’re going to try this radically different thing that’s probably tailored to what’s needed for software to be regulated. “”

He said the agency has concluded that it can leverage some of its existing regulators to launch the Pre-Cert program where possible, in hopes of eventually transforming it into the type of program that would be needed to effectively regulate digital health products.

Patel said the authorities the agency needs include the ability to use real-world evidence (RWE) generated from digital health products that can be incorporated into marketing authorization decisions.

“Moving to an ongoing oversight mechanism will require additional congressional authorities,” he explained.

According to Patel, other authorities are needed, including the ability to rely on a company’s own assessment to determine whether a product is brought to market and the ability to require companies to report on what they learn about their product based on RWE. He also said it was important for the FDA to implement the International Medical Device Regulators Forum (IMDRF) risk-based SaMD framework.

“There are some [authorities] we know and some [authorities] we will have to evolve with the times,” Patel said. “For example, what is considered a material change? Because even the machine learning algorithm can change, but maybe everything [shouldn’t be] considered important.

Advancing digital health

Patel has become a key figure in the FDA and more broadly in the digital health industry, especially as the industry has exploded in recent years. It is currently the fastest growing segment of the medical device industry, although a significant portion of digital health companies are technology-driven companies with little or no experience in regulations.

Patel said he realized that unlike other medical devices, digital health products such as SaMDs needed to be changed and updated constantly. While traditional medical devices can take years to update or change, digital health products may require monthly or weekly updating.

To address the issue, Patel first pitched the idea of ​​a pre-certified digital health program at the AdvaMed Digital Medtech 2017 conference. The program would create a new pre-market review pathway for digital health products where the FDA would allow updates without requiring subsequent 510(k) requests, as long as the agency trusted the manufacturer to maintain a certain level of excellence.

A number of experts at the recent MedCon conference praised the FDA’s Pre-Cert pilot program, but said it had gone as far as it could go. To go further, the agency needs new regulators from Congress, they added. (RELATED: MedCon: Industry Praises FDA’s Digital Health Pre-Cert Pilot, Regulatory guidance May 5, 2022)

Digital health journey

It wasn’t until February that Patel was promoted from director of the FDA’s Digital Health Center of Excellence to director of digital health for global strategy and innovation. So it came as a surprise to many that he decided to leave the agency.

“It was a shock to my colleagues, I think, and there were a lot of emotions that went through people,” he said. “It was really sad for me too. I had to think long and hard, ‘Is this really what I want to do, is this the next step in my career? And I’m really ready for something more big but I don’t know yet which is bigger.

Ultimately, Patel said he wanted to take his years of FDA experience to the next level. He said he believes he can help further advance the digital health sector by helping companies decide how to focus their resources and navigate the regulatory landscape.

“I feel like the FDA is in a really good place, we’ve done a ton of really good work in making the right policies, creating the right programs…holistically, I felt like to get to a point where I felt mission accomplished,” Patel said.

Patel said he didn’t like starting a task without finishing it, so even though he took on the role of the FDA’s director of digital health, he figured if he stayed on the job too long , he would invest too much in it.

“If I had to make a change, I would prefer to do it now because if I delayed it another six months to a year, I would be so deeply involved that I wouldn’t want to leave,” he said.

For Patel, the time was right as he felt he had achieved many of the goals he had set for himself.

“If you look at where the industry is going, where the investment and the energy are going, from what I’ve seen globally as we start to converge in this area, there’s still a lot of work to do,” Patel said. “Ideally, I’d like to play a role in guiding people to make the right investments, and that way we get meaningful solutions out there.”

He also said he cares deeply about equity and access to health care, which he sees as a global issue; the one he thinks he can have a greater impact on from outside the FDA. Specifically, he wants to continue working with international regulators to help them continue to evolve their work on digital health.

Now that he’s left the agency, Patel said the FDA should take his experience with digital health regulation and apply it beyond CDRH to other parts of the agency. There have already been discussions within the medical industry about whether the FDA’s Pre-Cert approach could be used for other types of products, where an assessment of manufacturer excellence and the use real-world evidence could be used to create faster pre-market pathways.

Regarding the industry, Patel said: “We are at a crossroads where I think almost all [medical device] FDA-regulated products will somehow be connected.

With that in mind, Patel said manufacturers need to understand that the FDA shares its intent to deliver the best products to patients in the best way possible. He said companies need to be open and transparent with the agency so they can work together to achieve common goals.

“If the industry invests in the digital nature of their products with analytics, I think that will be the best way forward for them,” Patel said.

However, Patel said one of the biggest obstacles facing digital health products is the lack of high-quality data. To address this, Patel said it’s important for the industry to understand its data profile, what it can do and what its limitations are.

“Start by knowing what you have and what it stands for, and how you want to take it and expand it,” he said. “If you really want to do something about equity and access to health care, I would say go get that data.”

Patel did not give further details on his future career, but he expects to start a new job in the private sector in the coming weeks. He is currently considering several prospects, but none of them would require him to uproot his life in Maryland.

© 2022 Society of Regulatory Affairs Professionals.


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