Outgoing CDRH digital health chief: Pre-Cert needs new legislative authorities

Regulatory NewsRegulatory News | 09 May 2022 |  By 

Bakul Patel, the US Food and Drug Administration’s (FDA) former digital health chief, said he’s always known the agency needed additional congressional authorities to fully implement a new digital health products pathway in an interview with Focus on Sunday.
On 30 April, Patel, longtime digital health director for FDA’s Center for Devices and Radiological Health (CDRH), announced on LinkedIn that he was leaving the agency after more than 13 years.
“It truly has been an incredible journey since 2008, -- from introducing the concept of ‘functionality-based regulations’ in the agency’s mobile medical apps guidance… to working with international regulators to create the term [software as a medical device (SaMD] to developing [FDA’s precertification (Pre-Cert) program]…to ultimately launching the Digital Health Center of Excellence,” he wrote.
New authorities
“We knew going into the concept of Pre-Cert that we would not be able to do it within our current authorities,” Patel told Focus. “If you look at the documents we put out earlier, we basically said, ‘Look we’re going to try this radically different thing which is probably tuned to what is necessary for software to be regulated.’”
He said that the agency concluded it could leverage some of its existing regulatory authorities to launch the Pre-Cert program to the extent possible, with the hope of eventually morphing it into the type of program that would be needed to effectively regulate digital health products.
Patel said the authorities the agency needs include being able to use real-world evidence (RWE) generated from digital health products that can be incorporated into marketing authorization decisions.
“Moving to a continuous oversight mechanism will take additional congressional authorities,” he explained.
Other authorities Patel said are needed include being able to rely on a company’s own appraisal to determine whether a product goes to market and being able to require companies report back what they are learning about their product based on RWE. He also said it is important for FDA to implement the International Medical Devices Regulators Forum’s (IMDRF) risk-based SaMD framework.
“There are some [authorities] we know and some [authorities] we would have to evolve over time,” said Patel. “For example, what is considered significant change? Because even machine learning algorithm can change, but maybe everything [shouldn’t be] considered significant.”
Moving digital health forward
Patel has become a key figure at FDA and in the digital health sector more broadly, especially as the sector has boomed in recent years. It is currently the fastest-growing segment of the medical device industry, though a significant portion of digital health firms are tech-focused companies with little or no regulatory experience.
Patel said he realized that, unlike other medical devices, digital health products such as SaMDs need to be continuously modified and updated. While it may take years to update or modify traditional medical devices, digital health products may require updating on a monthly or weekly basis.
To address the issue, Patel first floated the idea of digital health Pre-Cert program at the 2017 AdvaMed Digital Medtech Conference. The program would create a new premarket review pathway for digital health products where FDA would allow updates without requiring subsequent 510(k) applications, as long as the agency trusted the manufacturer to uphold a certain level of excellence.
A number of experts at the recent MedCon conference praised FDA’s Pre-Cert pilot program but said it had gone as far as it could go. To move further, the agency needs new regulatory authorities from Congress, they added. (RELATED: MedCon: Industry praises FDA’s digital health Pre-Cert pilot, Regulatory Focus 5 May 2022)
Digital health journey
It was only in February that Patel was promoted from director of FDA’s Digital Health Center of Excellence to chief digital health officer for global strategy and innovation, so it was 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 as well. I had to think really hard and long, ‘Is this what I really want to do, is this the next step in my career?’ And I’m really ready for something bigger but I don’t know what bigger is yet.”
Ultimately, Patel said he felt that he wanted to take his years of experience at FDA to the next level. He said he thinks he can help advance the digital health sector more by helping companies decide how to focus their resources and navigate the regulatory landscape.
“I feel like FDA is at a really good spot, we have done a ton of really good work from building the right policies, creating the right programs … holistically I felt like I’d come to a point where I felt the mission was accomplished,” said Patel.
Patel said he doesn’t like to start a task without finishing it, so even though he took on the role of FDA’s chief digital health officer, he figured if he stayed on the job too long he’d become too invested in it.
“If I was going to make a shift, I’d rather make the shift now because if I delayed it another six months to a year, I would be so far deep into it that I would not want to leave,” he said.
For Patel, the timing was right because he felt like he had reached many of the goals he set out to achieve.
“If you look at where the industry is going, where the investments and energy are going, from what I’ve seen globally as we start to converge in this area is there’s a lot more work to be done,” Patel said. “Ideally, I’d love to play a role in guiding people in making the right investments, and that way we get meaningful solutions out there.”
He also said that he cares deeply about equity and access to healthcare, which he sees is a global issue; one he thinks he can make a bigger impact on from outside FDA. More specifically, he wants to keep working with international regulators to help them continue to evolve their work on digital health.
Now that he’s left the agency, Patel said that FDA should take its experience with digital health regulations and apply it beyond CDRH to other parts of the agency. There have already been conversations within the medical industry whether FDA’s Pre-Cert approach could be used for other types of products, where a manufacturer excellence appraisal and the use of real-world evidence could be used to create faster premarket pathways.
As for industry, Patel said, “We’re at a junction where I think pretty much all [medical device] products regulated by FDA will in some way be connected.”
With that in mind, Patel said manufacturers need to understand that FDA shares their intent to get the best products out to patients in the best possible way. He said companies need to be open and transparent with the agency so they can work together to reach their common goals.
“If industry invests in the digital nature of their products with analytics, I think that will be the best way forward for them,” said Patel.
However, Patel said that one of the biggest hurdles digital health products face is the lack of high-quality data. To address this issue, Patel said it’s important industry to understand the profile of their data, what it can do and what its limitations are.
“Start off with knowing what you have and what it represents, and how you want to take that and expand it,” he said. “If you really want to do something about equity and access to health care, I would say go seek that data out.”
Patel did not provide any further detail about his future career, but he expects to start a new job in the private sector in the next few weeks. He’s currently looking at several prospects, but none of them would require him to uproot his life in Maryland.


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