More digital-based systems could help streamline the review process required to bring quality medical devices to the market in a safe and timely manner. Through its Digital Transformation Initiative, the U.S. FDA’s Center for Devices and Radiological Health (CDRH) aims to build a more robust, digital infrastructure to optimize the premarket review program for medical devices.
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.
Read the full article in at the U.S. Food and Drug Administration.