Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

FDA Statement

• For Immediate Release: January 07, 2019
• Statement From: Scott Gottlieb, M.D.

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 I 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. Since that announcement, we’ve been advancing policies that reimagine our oversight of digital health tools to be more efficient and promote patient safety throughout the product lifecycle. We’ve seen the promise of innovation in products like artificial intelligence software that can help alert physicians to a potential stroke and smart watches that can help identify atrial fibrillation. Today, we’re announcing that, based on the Pre-Cert pilot, we’ve drafted a regulatory framework to test new approaches for the review of digital health device applications.

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. We focused on ways to streamline our oversight of digital health products by reviewing and appraising the developer’s culture of quality and organizational excellence. 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. Today we’re issuing three documents that, together, launch us into the next phase of the agency’s vision of Pre-Cert. These components are a key step in advancing the Pre-Cert model. We look forward to obtaining public input as we implement these elements in the coming months.

First, one of the most important components is explaining our regulatory framework for the Pre-Cert program. We believe the most efficient way to test this type of program is to do so within the FDA’s current regulatory authorities. We know many stakeholders have had questions about how this would work. Today, we’re releasing our outline, titled Regulatory Framework for Conducting the Pilot Program within Current Authorities, to describe how the agency intends to use our De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot.

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. 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. These requirements are meant to demonstrate and provide assurance to the FDA that a manufacturer makes products that are safe and effective and meet the De Novo statutory standard. In 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. 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.

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. This year, we intend to test our pilot program to assess how Pre-Cert can maintain our standards for assuring safe and effective products, while still achieving its aim of modernizing and streamlining our review of novel digital health products. We want to test how the Pre-Cert approach utilizing the streamlined De Novo pathway compares to our traditional submission 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. 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.

As highlighted in the test plan, 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, as compared to the FDA’s approach in reviewing these devices under the traditional De Novo review process. The results and learning from this testing will provide input for refining our Pre-Cert program as well as confirm the validity of the concept envisioned in the Pre-Cert framework. At the conclusion of the testing and refinement, we expect to have confirmed that the evidence collected through the proposed Excellence Appraisal and streamlined De Novo submission meets the statutory requirements for granting marketing authorization.

Third, we are releasing today 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. This Excellence Appraisal step is followed by a review of the streamlined Pre-Cert De Novo request submission described in the Regulatory Framework, which would include submission elements and a manufacturer’s plan to monitor and evaluate the real-world performance of the software. Proactive monitoring of real-world performance enhances an understanding of how the software continues to perform while in use, while helping the developer and the FDA to quickly identify and address potential safety issues along with additional benefits to patients.

As I recently noted in an update on our Medical Device Safety Action Plan, access to robust and timely data, including more extensive and informative post-market data and real-world evidence, helps the FDA identify, communicate and act on new or increased medical device safety concerns. Such data serves as the foundation of our commitment to improving our nation’s post-market medical device surveillance. It’s one of the core pillars of our safety action plan. By utilizing the power of real-world performance data on software, Pre-Cert will help the FDA and developers better evaluate the real-world benefits and risks of these tools, and more quickly identify and address any issues and communicate safety information to patients.

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. Since launching the pilot program, we have been transparent about how we are building the program and have frequently requested and reviewed public feedback. 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.

Together, the plans we’re launching today demonstrate our ongoing commitment to building a Pre-Cert program that recognizes the unique and iterative characteristics of digital health products, as well as their significant potential to improve the lives of patients. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.