The American College of Radiology (ACR) submitted comments to the U.S. Food and Drug Administration (FDA) May 31, 2018, regarding the Software Precertification (Pre-Cert) Program Working Model (Version 0.1), a reimagined paradigm through which precertified companies/business units could have their Software as a Medical Device (SaMD) offerings regulated by the agency.
The working model is FDA’s draft skeletal framework for the Pre-Cert program with additional details scheduled to be fleshed out through the remainder of CY 2018 via additional information releases. The Pre-Cert program would evolve from a pilot into an initially limited, but ever-expanding launch in 2019. The working model describes at a high level the four primary components of the proposed Pre-Cert paradigm:
- FDA Appraisal of the company/business unit to ensure adherence to principles of excellence — The company would be awarded one of two levels of precertification status and maintenance of precertification will be required.
- Review pathway determination for SaMD from precertified companies — The SaMD must either undergo streamlined review or will be authorized to market without premarket review, depending on the SaMD risk categorization and, in certain cases, the precertification status of the company.
- Streamlined review of certain SaMD — If a given SaMD from a precertified company requires premarket review at all by FDA, it will benefit from an expedited review process as compared to the current regulatory paradigm for medical devices.
- Real-world performance monitoring, assessment, and data- eporting — Precertified companies that benefit from the program will be required to engage in adequate real-world performance monitoring of certain SaMD with post-market data reporting requirements.
In its comments, the ACR stressed the importance of determining the safety and effectiveness of SaMD on a product-specific basis and ensuring an even playing field for precertified developers without extensive FDA experience or resources.
The ACR encouraged the use of independent, qualified, third-party validation services and registries to support the various aspects of the Pre-Cert program, particularly the streamlined review and real -world performance monitoring components. The ACR also opposed any shift in liability to physicians or other end users as a result of SaMD regulatory pathway modifications.
For more information about FDA digital health efforts, including the Software Pre-Cert Program, please contact Michael Peters (firstname.lastname@example.org), ACR director of legislative and regulatory affairs.