- The FDA Software Precertification Program working model, while an important step toward regulating software more effectively, must be fleshed out to add clarity as the agency prepares to launch a pilot program next year, industry groups wrote in comments to FDA this week.
- The Clinical Decision Support Coalition, Medical Imaging & Technology Alliance and Consumer Technology Association offered feedback on the Pre-Cert program’s latest iteration, which aims to allow a select group of companies to bring certain digital health products to market without, or with a less burdensome, FDA premarket review.
- The CDS Coalition questioned the statutory authority of the agency to conduct a pilot test in 2019. "There is simply no legal authority anywhere in the existing statute or regulations to remove software as a medical device from the standard 510(k) process," wrote Brad Thompson, general counsel for the group representing software developers, in its comment.
In June, FDA released the second version of its software precertification working model with several changes to the initial proposal, including clarification that the long-term plan is to precertify both software as a medical device and software in a device and a plan to use a streamlined submission documentation review process compared to the traditional 510(k) review process.
The agency selected nine companies to take part, including Apple, Fitbit and Johnson & Johnson.
MITA said there must be more clarity over how FDA plans to implement the program given existing regulations, asking if the agency plans to use enforcement discretion on 510(k) submissions and other requirements to implement the new program.
Thompson said the plan to remove certain software from 510(k) review has no basis in congressional intent, arguing that it must undergo notice and comment rulemaking to comply with the Administrative Procedure Act, or seek new authority from Congress.
"At the end of this process, FDA needs to go to Congress to get authorizing statutory authority, and then implement the program through authorizing regulations," Thompson said. "As much as we like the program, we think it’s unavoidable that it will require new legal authority."
MITA also raised concern that the latest version would allow level 2 precertification, which allows companies to develop and market certain lower- and moderate-risk products without review, to companies with a track record of generally releasing products rather than only those with experience releasing medical devices.
"It is our position that Level 2 certification, in the initial program release should only be available to companies that have a track record of clinical validation, clinical risk management activities, and healthcare IT security associated with developing and releasing medical devices," wrote Patrick Hope, executive director of MITA, in the group's comment.
CTA, with members from a much broader set of companies including Sony and IBM, disagreed with MITA. CTA praised the change, calling it a "more inclusive threshold" for more companies to partake in the program. But CTA acknowledged that FDA should further define what types of products would determine level 2 eligibility.
"While it may well make sense to consider, for example, successful commercialization of non-FDA regulated Health IT products, it is unclear whether the Agency’s use of the term 'product' would extend to any type of product," wrote Michael Petricone, SVP of government and regulatory affairs at CTA, and Kinsey Fabrizio, senior director of member engagement and health and fitness technology at CTA, in the group's comment.
MITA said there should be a process for how the FDA can decertify companies if, according to Hope, they are "not as excellent as previously thought."