How CDRH’s Digital Transformation Initiative Will Strengthen the Premarket Review Program

By Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH, FDA
Twitter: @US_FDA

At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices. This includes our responsibility to review premarket submissions for certain new medical devices and modifications to devices currently on the market. As part of this ongoing work, the FDA continues to take steps to strengthen the premarket review program and make it more efficient, consistent, and predictable.

While the pandemic has challenged CDRH in many ways, it has also provided the center with opportunities to work together more closely, collaboratively, and quickly than ever before. As we increasingly use online platforms to support our work in a virtual, shared environment, such as premarket reviews, some of the systems we are building under our Digital Transformation Initiative will help us, and our stakeholders, improve the premarket review experience and save time and resources.

Building a robust infrastructure within the FDA and efficient external data interfaces with stakeholders are among the top priorities of the FDA’s Technology Modernization Plan (TMAP). The Digital Transformation Initiative, described below, reflects important near-term actions that the FDA is taking to achieve these top priorities and advance the FDA’s public health mission, which has been supported and will continue to be supported to a great extent by Congressional funding over the next several years. We have moved forward on a number of advancements, such as launching the Customer Collaboration Portal with the ability for sponsors to track their 510(k) submissions, developing SMART templates, and launching the eSTAR program after the pilot phase is completed. We also plan to launch an internal Decision Management Portal to make it easier for the FDA’s reviewers to find and use information.

Below, we’ve provided a brief update on each of these near-term actions.

Digital Transformation Initiative
CDRH’s Digital Transformation Initiative focuses on improving the user experience for customers both internal and external to the FDA, enhancing CDRH’s ability to accept, store, analyze, and distribute data, and digitalize CDRH’s programs and operations. There are currently more than 30 data systems utilized in CDRH for premarket review, and these legacy IT systems are outdated, complex, fragmented, and time-consuming to use. Additionally, we have limited ability to make improvements due to the high costs and the long times that it takes to complete them. In 2016, we determined it was no longer a good financial investment to pay to upgrade and maintain these old systems. Instead, we needed to invest in an integrated knowledge management system with secure cloud-based data storage that significantly improves data delivery to our staff and external stakeholders. These long-term, capital improvement efforts are part of our Digital Transformation Initiative.

Customer Collaboration Portal
The Customer Collaboration Portal is a secure, web-based dashboard that displays our progress in reviewing traditional 510(k) submissions. When a firm submits a traditional 510(k) to CDRH for review, the Official Correspondent can monitor its progress online in a simple, concise format. This important progress tracker fulfills one of our MDUFA IV commitments to build a secure, industry dashboard where the Official Correspondent can see the status of a submission in near real-time. After launching a small pilot program early in 2021, CDRH recently invited the Official Correspondents of all traditional 510(k)s to use the Customer Collaboration Portal to track the progress of the FDA’s review of their 510(k)s. The portal has been a tremendous success with over 100 logins every day during the first week. Looking ahead, our Customer Collaboration Portal will become a virtual workspace for the FDA, our sponsors, and other stakeholders, and we hope to expand this to other submissions in the future.

The development of the Submission Memo and Review Template (SMART) for 510(k) and De Novo reviews has been one of the most impactful changes in CDRH in recent years. SMART makes the administrative aspects of premarket review more efficient and consistent. The template, an automated guide used by reviewers to evaluate information across disciplines (e.g., biocompatibility, sterilization, cybersecurity) incorporates regulatory requirements and guidance expectations, and provides links to important resources, like FDA-recognized standards, as well as other decision support tools. We believe the efficiencies of SMART have the potential to strengthen review of other submission types across the total product life cycle.

eSTAR: An Interactive Aid for eSubmission of 510(k)s
The electronic Submission Template And Resource (eSTAR) enhances the quality of 510(k) submissions for a wide range of medical devices – from contact lenses to x-ray equipment to glucose test strips – by helping to ensure submitters provide quality, comprehensive data for the FDA’s premarket review. The 510(k) eSTAR is an interactive PDF form that closely follows the order and content of the 510(k) review as laid out in the SMART templates. With a standardized format, submitters can ensure their 510(k)’s are complete and the FDA’s reviewers can conduct these premarket reviews more efficiently. The content of the eSTAR for 510(k) is summarized in the FDA draft guidance, Electronic Submission Template for Medical Device 510(k) Submissions. The agency is accepting comments on the draft guidance until November 28, 2021. Right now, eSTAR can be used on a voluntary basis to construct a 510(k) submission. The date for mandatory use of eSTAR for 510(k) will be identified when the draft guidance is finalized. While eSTAR is currently only available for 510(k) submissions, the FDA intends to expand the eSTAR program to include other types of premarket and postmarket medical device submissions in the future.

Decision Management Portal
The Decision Management Portal is a new internal platform that aims to help CDRH staff evolve how we work today to stay ahead of tomorrow’s challenges by enabling reviewers to be more efficient in their day-to-day work. Once fully implemented the Decision Management Portal will provide a single location where CDRH staff can see all of their work, or the work assigned to their team, in a consolidated interface, rather than working from multiple siloed systems.

Next Steps
The Premarket Notification (510(k)) Program is a mature and robust program that represents the most common premarket regulatory pathway for new devices evaluated (or reviewed) by CDRH. In the coming decade, advances in technology will improve postmarket reporting capabilities and enhance our ability to monitor device safety. To meet our public health mission, it is critical that the FDA continues to evolve to help speed innovations that make medical products safer and more effective. The Digital Transformation Initiative and the dedication of our talented CDRH staff are key parts of the effort that continues to drive forward critical program enhancements. This program will ultimately provide better reporting tools that offer better therapies and diagnostic options for patients and health care providers with the ultimate goal of improving the health of millions of Americans.

This article was originally published on FDA Voices and is reprinted here with permission.