Health 1, 2017

Software Pre-Certification Pilot



Food and Drug Administration


Data quality, Safety,


The Software Pre-certification Programme is an initiative of the US Food and Drug Administration.
In order to implement the US Congress’ 21st Century Cures Act of 2016, which sought to streamline the drug and medical device approval process, the FDA’s Center for Devices and Radiological Health (CDRH) created a Digital Health Innovation Action Plan. The Plan issued guidance on the implementation of the legislation and included the launch of a pilot software precertification program to develop a new approach to digital health technology oversight. The work also builds on the FDA’s work since 2010 developing guidance in relation to mobile medical apps and working with software manufacturers.
The pilot Pre-Cert program explores a potential voluntary pathway to assess the safety and effectiveness of certain Software as a Medical Device (SaMD) products by focusing on the manufacturer/developer, rather than primarily the product. Companies that undergo the assessment may receive pre-certified status, based on their demonstrated robust culture of quality and organizational excellence, as well as the commitment to monitoring the real-world performance of their products. As a result, pre-certified companies would have a less burdensome route to market. This is a new approach compared to FDA’s standard method of individual product reviews and is meant to test the use of real-world evidence in evaluating the safety and effectiveness of new products.
One of the key challenges for regulation in this domain is that devices based on machine learning are not static but change over time, which calls for a new approach to the evaluation of safety and efficacy. The pilot is meant to inform the creation of a modern, flexible, risk-based approach to the regulation of quickly evolving digital health technologies, thereby reducing time and cost to market entry. It is an attempt at an innovation-enabling approach that still maintains the Agency’s scientific gold standard and ensures patient safeguards.
In September 2017 nine companies out of over 100 applicants were selected to participate in the development of the pilot program: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.
The program is being developed iteratively as mechanisms to measure real-world performance and risk-benefit benchmarks are established, and the FDA periodically releases its working draft of the pilot for public commentary. While Pre-Cert 1.0, the first version of the program is limited to manufacturers of SaMD, FDA will later offer the voluntary program to manufacturers of software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices. 
A test plan for running the pilot in 2019 with [font="Helvetica Neue", Helvetica, Arial, sans-serif]certain SaMD De Novo Requests has been released.

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