Senators Reiterate Concerns About FDA’s Software Pre-Cert Program
One year after questioning the US Food and Drug Administration (FDA) over its proposed approach to regulating digital health products through its Software Precertification (Pre-Cert) Pilot Program, Democratic senators say they still have concerns and are asking the agency for more information about the program.In an October 2018 letter to FDA, Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA) and Tina Smith (D-MI) posed more than two dozen questions about the program ranging from questions about the statutory basis for precertification to how the agency will handle postmarket surveillance for precertified products.
In addition to FDA’s response to the letter in June, the agency has also released several documents providing more information about the Pre-Cert program, including a working model for the program, a paper detailing the regulatory framework for conducting the program and a test plan for conducting the pilot in 2019.
In a letter dated Wednesday, the senators raise a new set of questions in response to FDA, taking issues with some of the same aspects of the program from the previous letter.
“It is essential that changes to the FDA’s regulatory framework are done in compliance with the current statutory framework and do not compromise public safety. Based on the updated materials you have provided us on the Pre-Cert Pilot Program, we continue to have concerns about the program,” the senators write.
Specifically, the senators say they continue to be concerned about three aspects of the program: the “excellence appraisal” FDA has proposed for reviewing developers; the appropriateness of the De Novo pathway as a statutory basis for the program; and the agency’s reliance on developer generated real world performance data.
FDA has explained that it plans to assess companies participating in the pilot based on five “excellence principles”: product quality, patient safety, clinical responsibility, cybersecurity responsibility and proactive culture. Adherence to these principles would be demonstrated using key performance indicators (KPIs) that FDA says companies would have some flexibility in selecting to “best meet” the regulatory requirements for the program.
In the letter, the senators question FDA on what types of data it is considering for the excellence appraisals; what limits the agency will place on applicants in choosing KPIs to demonstrate excellence; what elements of the excellence appraisal the agency plans to change or remove following initial testing of the program; what information from the appraisals would be publicly available; and whether the agency has determined that third-party entities will be able to conduct precertification assessments during the pilot.
The senators are also skeptical of FDA’s insistence that the De Novo pathway provides an adequate statutory basis for the program. “Does the agency believe that Congress intended for the pathway to be used to establish pilot programs that fundamentally alter the FDA’s existing method of device review and approval?” the senators ask.
Additionally, the Senators question the agency’s plan to rely on real world performance analytics (RWPA) to monitor precertified products in the postmarket setting.
“How does the FDA plan to ensure that the RWPA it receives from organizations are accurate, timely, and based on all available information,” the senators ask, noting that FDA has said it will not collect the raw data the analytics are based on.
Letter