FDA releases 2nd draft of its software pre-certification program

The FDA in June released an update to its original plan for the software pre-certification program, which the agency began piloting in September.

The software pre-certification program, which the FDA presented its initial version for in April, aims to streamline approval for digital health technologies by reviewing developers, rather than individual products. These pre-certified developers would be able launch products without review, so long as the developers collect post-market data to confirm product safety to the FDA.

The underlying premise of the program is that digital health products should be evaluated differently than traditional medical devices, since software is updated more frequently. The FDA established the program based on the idea a trustworthy software developer will likely continue to put out high-quality products, according to the Politico Morning eHealth newsletter.

The FDA plans to launch a large-scale pilot in 2019, building on lessons learned during its initial pilot with nine digital health companies, which included tech giants like Apple and Fitbit.

A key update within the new 45-page working model for the software pre-certification program involves the FDA's intention to expand the program to software used within traditional medical devices, such as programs that operate within an X-ray machine, according to Politico's newsletter.

To access the FDA's updated plan, click here.

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