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FDA Releases Software Pre-Cert Docs, Enters Next Phase of Pilot


Will the FDA’s pre-cert program expedite the review of digital health tools?


The U.S. Food and Drug Administration (FDA) today released a draft regulatory framework for its Software Precertification Program to advance its goal of better overseeing digital health tools.

With that, the FDA also announced plans to move forward in its pre-cert pilot program, which it launched with nine health-tech software developers, including Fitbit and Apple, about a year ago.

When established, the pre-cert program will be designed to ensure digital health software updates occur in a timely but properly regulated manner. The program would allow manufacturers who meet the FDA’s excellence principles and monitor their software’s real-world performance to go through a more tailored premarket submission process for their specific type of digital health tool, whether it be the software that runs a smartwatch or an artificial intelligence platform.

>> READ: FDA Releases Updated Software Precert Model

The agency issued three documents that make that vision one step closer to reality: the Pre-Cert Testing Plan, the Pre-Cert Regulatory Framework for Conducting the Pilot Program and the Pre-Cert Working Model Version 1.0.

The regulatory framework states that FDA will use its De Novo pathway for low- to moderate-risk digital health tools for the next phase of the program. Companies that submit their products under this pathway must meet Quality System Regulation requirements — demonstrating software design control and validation and good manufacturing processes.

In the pre-cert model, these requirements would be satisfied with the information collected through what the FDA calls an “Excellence Appraisal,” which evaluates the quality and excellence of the software developer. This information could streamline a developer’s submission, reducing the time it takes to get the product approved.

But the FDA will need to test the implementation of this reimagined pathway, something it intends to do through its Pre-Cert Test Plan. This guide n will help regulators assess how the Pre-Cert will maintain the agency’s standards for assuring safe and effective products, while modernizing and streamlining the review process of such digital health products.

To test the program, the agency will compare how the Pre-Cert program approach is using the streamlined De Novo pathway and the traditional submission pathway. So, the FDA will review a developer’s traditional De Novo submission for the device, and then review the Excellence Appraisal information with the streamlined submission content.

The agency believes the testing will confirm that the Excellence Appraisal and streamlined De Novo process meet the requirements for granting marketing authorization.

The third document released is an update to the working model, which helps the agency understand how well the program will work now and establish the components it envisions for the future of the program.

In the future, the FDA hopes to develop an expanded program that would leverage a manufacturer’s pre-certification status to the review of all its medical device software products.

Along with software as a medical device, pre-cert could help developers of software in a medical device and other software that could be accessories to hardware medical devices.

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