PHILADELPHIA — The FDA is not yet ready to go to Congress to seek new powers for its evolving precertification pilot for software, but it will need new authorities to determine how the experimental path fits into the current regulatory scheme, according to a top adviser to the agency.
"We're not drafting legislation at this stage. We're committed to showing the ... results. Does this work? What is the value proposition?" Marisa Cruz, senior medical adviser for digital affairs at FDA told a panel at the Regulatory Affairs Professionals Society conference in Philadelphia. "We need a clear outcome for the test plan before we go to Congress."
Apple, Johnson & Johnson and Fitbit are among the high-profile participants in the pilot, which entered a formal testing phase this year. The program is aimed at pre-certifying makers of software-based medical devices based on a so-called excellence appraisal, streamlined review and real-world performance plan. In this pilot phase, the agency will review each case on parallel tracks: via a traditional path like 510(k), De Novo or PMA, as well as the Pre-Cert.
Throughout, some in industry have questioned what the FDA can do without legislative authority. Democrats in Congress also have raised concerns over what legal powers the agency had to move the program forward.
Bakul Patel, FDA director for digital health, told MedTech Dive it is important for FDA to get the correct legislation the first time due to the difficulty getting changes through Congress.
“Before we go ask for exact features in a legislative proposal, it’s important to understand what those look like,” Patel said, on the sidelines of The MedTech Conference in Boston. “There’s a lot we can do under our current authority. I think we’ll find out as we start building the program is if we actually need more authority.”
Enforcement mechanisms and the decision of how Pre-Cert will fit into the current 510(k), De Novo and PMA pathways are among the details lawmakers will need to eventually address, Cruz said.
Because Pre-Cert is not enshrined in any law, enforcement will be tricky, according to Ben Zegarelli, an attorney at Mintz Levin. That's because recalls and warning letters now are based on a product's FDA clearance, not a company's process, excellent or not.
"If we take a look at what FDA can do right now it's sort of limited from an enforcement perspective," Zegarelli said. "Rescinding a 510(k) or De Novo is not really done ... as an organization there might be an issue going back to the excellence appraisal."
A potentially quicker path to market based on the excellence appraisal of a company rather than a specific product means more rigorous collection of data post-market incorporated into approvals or expansions, Cruz said.
"We need to understand what Congress will support. I think everyone believes we need an enforcement framework," Cruz said. "We envision a much more robust postmarket data collection than we currently have."
On that front, the agency will need to rely on real-world data elements.
"There is an opportunity to use well structured real-world performance data to help support a clinical claim or an expansion of claims," Cruz told MedTech Dive. "It needs to be done ... the right way, certainly with advance discussion with the agency on what an appropriately structured clinical study would look like using real world performance data."
One expert warned fitting the Pre-Cert program into current authorities will pose challenges due to its aspirations.
"We're trying to fit Pre-Cert into an existing regulatory model, when it really envisions a new way of doing things," said Aaron Josephson, an advisor with ML Strategies.