FDA new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

  • Posted on: 9 January 2019
  • By: Shalini.Sharma


Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.

That’s why FDA announced in the Digital Health Innovation Action Plan that the FDA would pilot a Digital Health Precertification (Pre-Cert) Program to make sure that patients continue to have access to new treatments that meet our gold standard for safety and effectiveness.

Our goal in piloting the Pre-Cert Program was to support the development of new technologies that are frequently updated, as well as to learn from software developers about the unique nature of their products. Our aim has been to develop a Pre-Cert program that would allow developers who have been assessed by the FDA for meeting specific excellence principles—known as an “Excellence Appraisal”—to participate in a more tailored premarket submission process appropriate for their specific type of digital device.

Our digital health team has been working with patients, providers, the nine diverse companies participating in the Pre-Cert pilot program and other stakeholders to build this framework.

First, one of the most important components is explaining our regulatory framework for the Pre-Cert program. 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.

Second, to further refine how this De Novo process would work for Pre-Cert, we need to test this type of implementation, which is why today we also released our Pre-Cert Test Plan for 2019. 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.

Third, we are releasing an update to our Working Model that incorporates the Regulatory Framework and Test Plan described above, which will help us understand how well Pre-Cert will work now, but also help us establish the components we envision for the future of Pre-Cert. The Pre-Cert model begins with appraising the excellence of the firm and reviewing related documentation, including elements corresponding to De Novo submission content and Quality System requirements and documenting that review.

The Working Model describes the proposed approach for implementing Pre-Cert under our current authority. It also outlines the agency’s broader vision for Pre-Cert.

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