FDA recently issued an initial working model for its Software as a Medical Device ("SaMD") Precertification Program. The model consists of four program components and is aimed at enabling streamlined oversight of trusted SaMD manufacturers. It will be tested with the help of the nine participants enrolled in the Software Precertification Pilot Program, which was implemented in 2017 to establish a more efficient, risk-based approach to regulating digital health technology and to foster innovation in the digital health space.
The first component of the working model involves an "excellence appraisal" and certification process for SaMD manufactures. Initial precertification for eligible businesses will be evaluated on five principles: commitment to developing and maintaining high quality SaMD products, patient safety, clinical responsibility, cybersecurity protection, and proactive approaches to identifying user needs. FDA envisions two tiers of precertification and an automated path for maintaining precertification status once it is achieved.
The second component focuses on "review pathway determination." The pathway determination process provides a risk-based framework to determine whether, and to what extent, a SaMD product requires review. FDA intends to utilize the risk categories established by the International Medical Device Regulatory Forum and will require SaMD manufacturers to provide a definition statement to help place products in the different risk categories. Based on a product's risk category, as well as a manufacturer's precertification status, a SaMD product could potentially qualify for a streamlined premarket review or no review.
The next component addresses the streamlined review process. FDA does not currently have a proposed model, but it envisions a review in which it will provide a decision on the marketing of a precertified company's SaMD product within a shorter timeline than other processes. A precertified company would provide its definition statement and an overview of intended uses during an interactive review with FDA. FDA would also interactively review any supporting information, such a through screen sharing and accessing product development environments. After the interactive review, FDA would provide its premarket decision to the manufacturer.
Finally, the fourth component focuses on gathering real world performance data and analytic methodologies for precertified activities. For example, to verify the ongoing safety of a SaMD product, which may change with technological developments, all precertified manufactures will be required to monitor real world performance data and to share that data with FDA. FDA intends to use the data for monitoring and feedback at product, organizational, and program levels. The data may inform FDA decisions related to individual products and to the precertification status of a SaMD manufacturer.
The working model includes specific questions to the public related to each of the four components. FDA is actively seeking public input to improve the working model.
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