The FDA released draft regulatory framework and complimentary documents detailing its plans to streamline the review of digital health devices, including artificial intelligence (AI) technology, under its Software Precertification (Pre-Cert) initiative.
In the initiative's new Regulatory Framework for Conducting the Pilot Program Within Current Authorities, the FDA details how it plans to implement the Pre-Cert program under the De Novo pathway.
“Our De Novo pathway is well-suited to meet the goals of our Pre-Cert program because it is a pathway for certain novel types of low-to moderate-risk devices to obtain marketing authorization,” FDA Commissioner Scott Gottlieb, MD, said in a prepared statement. “Currently, firms submitting products for review under the De Novo pathway must also meet applicable Quality System Regulation (QSR) requirements, which include demonstrating software design control and validation, and current good manufacturing practices.”
Under the Pre-Cert model, many of these QSR requirements would be satisfied by information the FDA collected through the Excellence Appraisal process, which is aimed at evaluating the quality and excellence of the software developer for Pre-Cert, Gottlieb wrote.
The FDA has also published its Pre-Cert 2019 Test Plan, which explains how the agency will test the more efficient De Novo pathway.
“To do so, we will review the sponsor’s traditional De Novo submission for its device and using that same submission information we will, in parallel, review the sponsor’s Excellence Appraisal information with the proposed streamlined submission content,” Gottlieb said. “The sponsor will incur no additional burden. Instead, the FDA will set up two parallel review processes, one using the Pre-Cert model and one using the traditional approach to the review of a De Novo application.”
This approach will help the FDA show that the combined assurance resulting from the proposed Excellence Appraisal and streamlined premarket review submission will provide the same quality and type of information necessary for the FDA’s determination of whether a software developer’s products meet the statutory safety and effectiveness standard, Gottlieb said.
The FDA also released a draft of its Working Model. It incorporates the new regulatory framework and test plan and explains the proposed implementation approach and the agency’s overall vision for the Pre-Cert program.
A recent graduate from Dominican University (IL) with a bachelor’s in journalism, Melissa joined TriMed’s Chicago team in 2017 covering all aspects of health imaging. She’s a fan of singing and playing guitar, elephants, a good cup of tea, and her golden retriever Cooper.