Three Democratic senators, led by presidential candidate Sen. Elizabeth Warren (D-Mass), are again raising concerns about the U.S. Food and Drug Administration's Software Pre-Certification program, arguing that the agency is working outside the boundaries of its statutory authority.
As first reported by STAT, Warren, along with Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Patty Murray (D-Wash.) and Senator Tina Smith (D-Minn.), sent a letter (PDF) to acting FDA Commissioner Norman Sharpless, M.D., and Jeffrey Shuren, M.D., director for the Center for Devices and Radiological Health within the FDA. They requested more information about how the pre-cert program will remain in compliance with the current statutory framework.
The FDA developed the precertification pilot program to streamline the approval process for low-risk digital health and health software products by focusing on reviewing and certifying the developer of potential digital health products rather than the products themselves.
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The precertification pilot program, announced in 2017, has gained widespread industry support. Last September the agency announced nine companies—including Apple, Fitbit and Verily—would be part of an initial pilot to develop a working model that evaluates software developers rather than individual devices.
The lawmakers said they support the program but remain focused on ensuring it does not negatively impact public health.
"Digital health devices can be innovative, transformative, and have the power to alter America's health landscape. We support the agency's efforts to update its medical device review regime to better accommodate digital health devices," the senators wrote in the letter.
A year ago, the same three senators expressed similar concerns in a letter to the FDA, and in June the agency responded with answers to their questions.
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Despite receiving more information about the Pre-Cert Pilot program from the FDA, the senators said they continue to have concerns, primarily around the agency's ability to ensure public safety under a "precertification" model, particularly around the use of "Excellence Appraisals." These appraisals are the FDA's approach to evaluate a software manufacturer's organizational capacity to produce products that are safe for the public. Through this process, the FDA looks at five elements—product quality, patient safety, clinical responsibility, cybersecurity responsibility, and proactive culture.
The senators also have concerns about the appropriateness of the De Novo pathway as a statutory basis for the pilot, they wrote in the letter.
In its June 2018 response to the senators' questions, the FDA asserted that the "De Novo pathway is well-suited to meet the goals of the Pre-Cert program because it is a pathway for certain novel types of low-risk to moderate-risk devices to obtain marketing authorization," according to the letter.
Third, the senators highlighted the agency's use of real-world performance data to assess the safety and efficacy of software as a medical device approved through the pilot. The lawmakers questioned how the FDA plans to ensure that the real-world data it receives from organizations, such as data from electronic health records, are accurate, timely, and based on all available information, according to the letter.