FDA plans to launch ‘Pre Cert 1.0’ by the end of 2018, issues working model for digital health regulation

The Food and Drug Administration plans to launch a full-scale version of its digital health precertification program by the end of the year.

Dubbed “Pre Cert 1.0,” the program will be the first formal iteration of a pilot project launched with nine companies last September. The agency plans to build the program using a working model (PDF) and an updated roadmap, released on Thursday, that evaluates each manufacturer’s transparency, culture of quality and organizational excellence rather than the product itself. 

The agency plans to further refine the program throughout 2019, FDA Commissioner Scott Gottlieb, M.D., said during a speech at Health Datapalooza in Washington, D.C., on Thursday.

“This is the first, high-level draft of what will be several iterations of our working model for this new program,” he said. 

RELATED: Apple and Fitbit among the 9 companies selected for FDA’s coveted digital health pilot

The FDA considers the public and industry stakeholders the pilot program’s tenth participant, and Gottlieb called for feedback to refine the framework.

“The critical piece we need moving forward is input from developers, patients, providers, stakeholders and members of the public,” he said. “Once we determine the elements for a future precertification program, we will then consider the appropriate mechanisms for establishing the program, including FDA's current statutory and regulatory authorities.”

The agency also plans to use a similar approach to support digital health tools used in conjunction with prescription drugs. Gottlieb cited several examples where mobile tools can improve the safety and effectiveness of certain medications, including medication compliance apps that feed data into EHRs, or software that uses a cell phone camera to classify pain symptoms for cancer patients.

RELATED: FDA’s Scott Gottlieb wants to use funding boost to create a Center of Excellence on Digital Health

Gottlieb said the FDA will be “advancing a policy framework” by releasing new guidance later this year on regulating software used with prescription drugs. The agency is also launching a new "digital health incubator" aimed at uncovering new health technology and advanced analytics related to cancer care.

“We want to facilitate innovation in this space,” he said.  “It has the potential to make drug development more effective and efficient and make care more personalized to the patient.”

Gottlieb also briefly touched on the FDA's approach to regulating artificial intelligence, the technology he said "holds enormous promise for the future of medicine," but requires a new approach to regulatory oversight given the new complexities that AI and machine learning bring to the table. 

RELATED: After a 6-year wait, FDA’s clinical decision support guidelines get a mixed reaction

FDA plans to use lessons learned from the digital health precertification program to its inform its approach to AI oversight. 

"Employing the pre-cert approach may allow a firm to make certain minor changes to its devices without having to make submissions each time," he said. "And, we’ll make sure that other aspects of our regulatory framework, such as new software validation tools, are sufficiently flexible to keep pace with the unique attributes of this rapidly advancing field."