FDA chief Dr. Scott Gottlieb announced today the next steps for his agency’s digital health pre-certification pilot program.
“Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation,” he said in a statement.
The program, which launched in October of 2017, was designed to streamline the review of digital health products by appraising developers and giving them the chance to participate in a more tailored premarket submission process.
Today, the agency issued three documents to kick off the next phase of the FDA’s pre-cert model.
The first was an outline describing how the FDA plans to use its de novo submission pathway in the pre-cert model. Device-makers that submit their application via the de novo pathway have to meet certain quality system regulation requirements, including software design control and validation and good manufacturing practices – it’s not unlike the information collected during the “Excellence Appraisal” part of the pre-cert process, the FDA noted.
“By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo submission, reducing content the developer would need to submit to the agency under the De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal. This allows the FDA to tailor the premarket submission content to the unique considerations related to each particular digital health device and enables more efficient evaluation of low-risk digital health devices,” Gottlieb explained.
The second item released by the FDA was a test plan for 2019. This year, the agency plans to test how the pre-cert program (using the streamlined de novo pathway) compares to the traditional regulatory pathway in reference to safety and efficacy measures. To do so, the FDA said it will review sponsors’ traditional de novo submissions and, in parallel, review the sponsors’ Excellence Appraisal information with the proposed streamlined submission content.
Finally, the FDA published an update to its Working Model to clarify how the pre-cert pilot works now and how the agency wants it to work in the future.
“In this third draft of the Working Model, the public will see how we’ve incorporated into the model the extensive feedback received and we look forward to additional engagement on this version and the other documents released today,” Gottlieb said. “Our new actions will promote the development of novel, beneficial technology while ensuring that patients have access to high quality, safe and effective digital health devices.”
