By: Jeff Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH) and William Maisel, MD, MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH

At the United States Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), we’re committed to protecting public health by ensuring patients have faster access to safe, effective, and high-quality medical devices. This includes our responsibility to review pre-market applications 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 pre-market review program and make it more efficient, consistent and predictable.

Photo by Jeffrey E. Shuren, MD, JD
Jeff Shuren, MD, JD

While the pandemic has challenged the CDRH in many ways, it has also provided the center with opportunities to work together more closely, collaboratively, and faster than ever before. As we increasingly use online platforms to support our work in a shared virtual environment, such as pre-market reviews, some of the systems we are building as part of our digital transformation initiative will help us, as well as our stakeholders, improve the pre-market review experience and save time. and resources.

Building a robust infrastructure within the FDA and effective 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 the important, short-term steps the FDA is taking to achieve these top priorities and advance the FDA’s public health mission, which has been and will continue to be supported. to a large extent by funding Congress over the next few years. We have made progress 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 models, and launching the eSTAR program after phase pilot completed. We also plan to launch an internal decision management portal to make it easier for FDA reviewers to find and use information.

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

Digital transformation initiative

CDRH’s digital transformation initiative focuses on improving the user experience for internal and external customers of the FDA, by strengthening the CDRH’s ability to accept, store, analyze and distribute data, and to digitize data. CDRH programs and operations. There are currently over 30 data systems in use in CDRH for pre-market review, and these legacy computer systems are outdated, complex, fragmented, and time-consuming to use. In addition, we have a limited ability to make improvements due to the high costs and the time it takes to complete them. In 2016, we determined that it was no longer a good financial investment to pay to upgrade and maintain these older systems. Instead, we needed to invest in an integrated knowledge management system with secure cloud-based data storage that dramatically 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

William Maisel, MD, MPH
William Maisel, MD, MPH

The Customer Collaboration Portal is a secure web-based dashboard that displays our progress in reviewing traditional 510 (k) submissions. When a company submits a traditional 510 (k) to the CDRH for review, the official correspondent can track their progress online in a simple and concise format. This important progress monitoring tool fulfills one of our MDUFA IV commitments consisting in creating a secure and industrial dashboard where the official correspondent can see the status of a submission in near real time. After launching a small pilot program in early 2021, the CDRH recently invited official correspondents from all traditional 510 (k) to use the Customer Collaboration Portal to track the progress of the FDA review of their 510 (k). s. The portal was a huge success with over 100 connections every day during the first week. Going forward, our customer collaboration portal will become a virtual workspace for the FDA, our sponsors and other stakeholders, and we hope to expand it to more submissions in the future.


The development of the Submission Score and Exam Template (SMART) for 510 (k) and De Novo exams has been one of the most significant changes at CDRH in recent years. SMART makes the administrative aspects of pre-market review more efficient and consistent. The template, an automated guide used by reviewers to assess information across disciplines (e.g., biocompatibility, sterilization, cybersecurity) incorporates regulatory requirements and guidance expectations, and provides links to important resources, such as FDA recognized standards, and other decision support tools. . We believe that the effectiveness of SMART has the potential to strengthen the review of other types of submissions throughout the product lifecycle.

eSTAR: an interactive help for the electronic submission of 510 (k) s

The electronic submission template and (eSTAR) resource improves 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 that Bidders provide comprehensive, quality data for the FDA’s pre-market review. The eSTAR 510 (k) is an interactive PDF form that closely follows the order and content of the 510 (k) exam as shown in the SMART Templates. With a standardized format, bidders can ensure their 510 (k) is complete and FDA reviewers can perform these pre-market reviews more efficiently. The content of the eSTAR for 510 (k) is summarized in the proposed FDA guideline, Electronic Submission Template for Medical Device 510 (k) Submissions. The agency is accepting comments on the draft guidelines until November 28, 2021. Currently, eSTAR can be used on a voluntary basis to create a 510 (k) submission. The mandatory eSTAR use date for 510 (k) will be identified when the draft guidelines are finalized. Although eSTAR is currently only available for 510 (k) submissions, the FDA intends to expand the eSTAR program to include other types of pre-market and post-market 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 the way we work today to stay ahead of the challenges of tomorrow by enabling reviewers to be more efficient in their daily work. When fully implemented, the Decision Management Portal will provide a single location where CDRH staff can view all of their work, or work assigned to their team, in a consolidated interface, rather than working from multiple systems. partitioned.

Next steps

The pre-market notification program (510 (k)) is a mature and robust program that represents the most common pre-market regulatory route for new devices being evaluated (or reviewed) by the CDRH. Over the next decade, advancements in technology will improve post-market reporting capabilities and strengthen our ability to monitor device security. To fulfill our public health mission, it is essential that the FDA continues to evolve to help accelerate innovations that make medical products safer and more effective. The Digital Transformation Initiative and the dedication of our talented staff at CDRH are key elements of the effort that continues to advance critical program improvements. This program will ultimately provide better reporting tools that will provide better therapies and diagnostic options for patients and healthcare providers with the ultimate goal of improving the health of millions of Americans.