The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.
Earlier this week the FDA hosted two workshops to discuss the future of the program with stakeholders.
“We have a situation where the manner in which the FDA is reviewing software is going to have match the way the way our industry makes software, and so that was a big part of this discussion,” Morgan Reed, the President of ACT | The App Association, who attended the two-day workshop, told MobiHealthNews.
Software is often updated in iterations, with quick updates over a period of time. But, as of now, each product and any change to a piece of software has to go through the FDA submission process.
“Because of software’s faster iterative design, development, and validation, traditional implementation of the premarket requirements may impede or delay patient access to advances in software technology that would improve public health,” the FDA wrote in a Pre-Cert update ahead of the workshop. “Since issuing the action plan, we have partnered with a range of digital health software companies and other stakeholders to begin developing a precertification program that could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others.
While there is general consensus that the FDA needs a new process, exactly how the changes would be implemented is unclear.
“At the end of the day this is an exchange of responsibility. What we are talking about is coming up with a new model that focuses more on the who than the what,” Bradley Thompson, an FDA expert and attorney at Epstein Becker Green, told MobiHealthNews. “From an industry standpoint the only reason you would be interested in doing that is if it makes your life better or easier, if you can get to market more quickly and without overall increase in cost of doing business.”
The FDA has come up with some initial “excellence principles,” which include patient safety, product quality, clinical responsibility, cybersecurity responsibility, and proactive culture. But figuring out what those look like in practice is a different story.
“A lot of the work was around identifying what are key fundamental principles around what is high quality development and what are the indicators that can be used to make metrics around those indicators,” Reed said. “What are the current industry standards that define excellence in software development [and] what are the global standards and how do we turn that into [something] the FDA measures.”
But there is some indication what the FDA metrics might look like. The agency released a draft of appraisal questions.
“I think right now the system that we are contemplating is a little bit over the top,” Thompson said. “I look at the assessment model and I see 150 questions on the website. I think that is a lot. That would be burdensome for companies. Would they do it? Well, they might if that made [the devices] freely flow to market.”
Those 150 draft appraisal questions ask everything from “How does your organization prioritize a culture of proactivity?” to more concrete questions like “How do you leverage real-world evidence in improving patient safety?”
Multiple workshop attendees have commented that translating ideas and theories into metrics is difficult. There has also been some difficulty putting the terminology from multiple companies and agencies into a common language.
“One of the challenges has been terminology,” Howard Look CEO of Tidepool, a company currently in the Pre-Cert pilot program, wrote in his blog post. “Regulatory Professionals often use different language than software people, so we've been working hard to use terms that software team will understand. A software engineering team at a small startup should be able to read and understand what they need to do to deliver software that will benefit public health.”
There has also been a lot of discussion around making the program fair for companies of any size.
“I think that is an extremely challenging issue and I don't know if the FDA has fully grappled with that,” Thompson said. “Is it going to be objective enough? A lot of factors are really 'squishy. How do you make sure they are treating even similar companies the same way and how do you account for substantial difference and come up with something that is fair?”
The FDA has affirmed its commitment to keeping the program open to all companies regardless of size.
“The FDA’s Digital Health Pre-Cert Public Workshop meeting was a very positive event. Digital innovators across consumer health and wellness to therapeutics came together with FDA regulators, biopharmaceuticals, medical devices, patient, payer and physician stakeholder groups," Yuri Maricich, chief medical officer and head of clinical development at Pear, wrote in an email to MobiHealthNews. "There was an attitude of true collaboration. The FDA brought together a diverse collection of stakeholders."
But Thompson questioned whether the program should even be called a pilot program.
“The FDA has to be honest and say it is not a pilot. In no way is it a pilot,” he said. “A pilot is when you have a system and you apply it to a few companies to vet to see how the system works and at the end you say, 'How did that work?' There is no pilot here. They have spent the whole year designing something. That’s not a pilot. That is design work. I didn’t fully appreciate that until they came to the meeting and then they just had discussions on what they think it aught to look like until the end of the year.”
If the pilot goes well and Pre-Cert discussions finalize in the future, startups could potentially go straight into the program before launching any products.
“If Pre-Cert is done the right way, then Pre-Cert becomes something you start with and that your funders will say, lets go to the Pre-Cert concept from day one and you’ll have a quicker path to launch,” Reed said.
But with regulations being loosened, many are questioning what kind of oversight will there be for companies once they are approved. Thompson said this question has left many frustrated. For example, while the meetings did touch on potential auditing, no concrete decisions came out of the talks.
“One of the things discussed was, what is good today might not be good tomorrow,” Reed said.
Although the specifics are still murky, the pre-certification program could change the course of the digital health industry. Thompson said figuring out the logistics is a huge undertaking by the FDA, and gives the leaders there a lot of credit for starting the discussion.
“What the FDA is doing here is nothing short of a revolution in how digital health apps will be regulated,” Look wrote in an email to MobiHealthNews. “It's an incredible opportunity that will make a huge difference in innovators' ability to deliver safe, effective software that will benefit public health.” Nike LunarEpic Flyknit