FDA Implementing Software Pre-Certification

FDA says it plans to implement the Software Precertification Pilot Program under the de novo pathway as described in a regulatory framework paper. The paper says the goal of this phase of the pilot is to “determine the contours of a possible regulatory model that provides efficient regulatory oversight of certain software-based medical devices from manufacturers who have demonstrated a robust culture of quality and organizational excellence and are committed to monitoring real-world performance while assuring that these devices are safe and effective.” The pilot also is to inform the agency as to whether it should seek other regulatory authorities to implement a modern, more effective, proactive, and efficient regulatory framework for software-based medical devices.

The paper says that after testing and validating the framework provided in a 1/2019 Working Model paper, the agency plans to use the de novo pathway to authorize marketing and establish special controls for software as medical device products and to further test the total product lifecycle approach of the pre-certification program. “In this way,” it says, “FDA will, consistent with its current authorities, continue to explore the possibilities of precertification through an innovative pilot program while also providing reasonable assurances of the safety and effectiveness of software devices.”