With a proposed deadline of 9 November, three US senators sent a letter to the US Food and Drug Administration (FDA) on Wednesday to request more information on the agency’s pre-certification program for digital health.
FDA’s Center for Devices and Radiological Health (CDRH) recently adapted
its regulatory processes to the rapidly evolving nature of digital health, while also encouraging questions like those from Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA) and Tina Smith (D-MI).
The 12-page letter, which calls for answers to more than two dozen questions, supports FDA’s position on the need for a new approach tailored to digital health. The request seeks to ensure that FDA’s gold standard of safety and efficacy is safeguarded throughout this process.
The letter comes a few weeks after FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren issued a joint statement to highlight two de novo clearances the agency granted
for new mobile medical apps for use on the Apple Watch. The world’s most valuable company is one of the nine participants selected
last year to help provide routine feedback to CDRH’s Pre-Certification (Pre-Cert) program.
The Pre-Cert program, however, is still in development and will not become operational until next year. Bakul Patel, CDRH associate director for digital health, clarified at the MedTech Conference that neither of Apple’s de novo requests underwent a review with a Pre-Cert approach. Still, the senators’ letter makes reference to these clearances, underscoring the confusion.
The questions outlined in the letter are separated into four areas related to the agency’s use of the proposed framework for the Pre-Cert program. These include the agency’s existing statutory framework for precertification, qualification for precertification, effective monitoring and postmarket surveillance, as well as FDA’s capacity to oversee digital health products.
FDA’s goals for a new regulatory framework “are worthy goals,” the senators touted. “However, the statutory basis for FDA's deployment of this more agile, tailored framework is unclear in several important respects,” they added, pointing to the agency’s Pre-Cert working model.
The agency has stressed throughout the co-creation process that it intends to work within its current authorities to establish the Pre-Cert program. Patel previously told Focus
the agency’s goal is to develop Pre-Cert version 1.0 by December 2018 and have the program “available for pilot testing within FDA’s current statutory and regulatory authorities in 2019.”
Earlier this year, CDRH indicated
testing of the first version of the pilot would begin this year.
The letter echoes the concerns that emerged over this issue, following the June release
of the Pre-Cert working model. “It is unclear from FDA's working model what specific statutory and regulatory authorities FDA is utilizing to conduct the precertification program or whether FDA anticipates needing new statutory authority to precertify entities outside of a pilot,” the senators write.
The Pre-Cert working models are released in conjunction with “challenge questions” designed to help CDRH and the nine participating companies tackle issues associated with different components of the proposed framework that have yet to be fully defined.
In public comments to FDA on the Pre-Cert working models, some device makers have also raised
concerns around how the agency intends to support market authorizations.
"It is again unclear what statutory authorities FDA would rely on to establish a ‘phased market authorization’’ program that allows SaMDs [Software as a Medical Device] to be legally marketed without sufficient evidence to support full market approval,” the senators said.
Under the program’s proposed framework, determinations on precertifications will be made based on a company’s ability to meet a threshold of organizational excellence. This, in turn, is intended to provide time and cost savings associated with reduced regulatory burden. It is also aimed at helping to achieve FDA’s goal to strike a balance between pre- and postmarket data.
“Software companies could be allowed to use an entirely self-policing review system in order to maintain a status that affords them valuable access to a streamlined review process, even for high-risk software and even if they have no prior experience marketing medical devices,” the senators added. “This approach raises serious concerns about how FDA would ensure compliance with the goals and requirements of the precertification program.”
Yet another concern the senators have relates to the role of the National Evaluation System for Health Technology (NEST). They noted that the success of Pre-Cert has been linked to the use of NEST, referring to the real-world evidence (RWE) safety net that is still in development as “a collection of electronic health records, clinical registries, billing claims, and other data.”
“The first pre and postmarket NEST pilots mandated under MDUFA IV and the FDA Reauthorization Act of 2017 are not due to begin until 2019 and August 2018, respectively, and will not be evaluated until the end of this user fee cycle,” according to the senators. “Given NEST's infancy, we are concerned about its readiness to support the type of hands-off approval and clearance process FDA is proposing for SaMDs.”
In reaction to the senators' letter, FDA spokesperson Stephanie Caccomo told Focus
the agency continues working with stakeholders to design the Pre-Cert model while exploring ways to execute the pilot within the existing statutory authorities. The agency intends to issue a response directly to the three senators, according to Caccomo.
"We have been transparent about our proposed working model for the program, including seeking public feedback, and will be publishing the next iteration in December," Caccomo added. "We will continue to solicit public feedback as we continue developing the Pre-Cert pilot throughout 2019."
Anyone interested in providing formal comments or submitting questions on the Pre-Cert pilot can do so when visiting the agency's website
by accessing the online portal or sending an email to the Pre-Cert team.