On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program.  It is the only public update on the program in 2020.  According to the update, FDA will continue to evaluate its Pre-Cert program, which currently is only in pilot form.  Perhaps disappointing to many companies, the update did not suggest that FDA will be adding new participants to the pilot program at this time, nor did it signal that the program would be fully operational anytime soon.

Brief Background

The Pre-Cert Program was launched as a pilot program at the end of 2017 with the participation of nine select companies.  The goal of the program is to develop a streamlined premarket review process for software as a medical device (SaMD) that would enable developers to introduce software iterations and changes under tailored regulatory controls (and without necessarily submitting a new 510(k) notification).  The program would leverage a company’s demonstrated culture of quality and product postmarket performance through monitoring of real-world performance data.

The Pre-Cert Program has four essential components designed to reflect the total lifecycle of the product: (1) Excellence Appraisal; (2) Review Determination; (3) Streamlined Review; and (4) Real-World Performance.  Throughout 2018, FDA solicited feedback from stakeholders, which continued into 2019.  In early 2019, the Agency released the Working Model version 1.0 and Test Plan, followed by a mid-year update that disclosed learnings on the Excellence Approval component.  The Agency largely has been silent on the Pre-Cert Program since then.

Learnings To Date – Key Takeaways

The update provides detail on FDA’s activities under its Test Plan, and the below extracts key learnings and next steps for components of the Pre-Cert Program.

Excellence Appraisal.  The intent of the Excellence Appraisal is to create a structured approach for collecting objective measures of a company’s culture of quality and product performance, and develop a library of activities, processes, and key performance indicators (KPIs) used by high performing organizations.  FDA has conducted mock appraisals of the pilot participants to test different methods and approaches of collecting KPIs and other metrics (e.g., number of complaints, product defects).  While FDA has developed an initial KPI library from information collected during the mock appraisals, the Agency still has to determine whether those KPIs actually reflect an organization’s culture and product performance.  FDA also will refine the KPIs to model and test scenarios for Pre-Cert excellence thresholds.

Streamlined Review.  FDA is comparing reviews of traditional premarket submission packages with mock Streamlined Reviews of data collected from the pilot participants in order to determine the comparability of the review processes.  During the comparison, FDA has found variability in the information needed to achieve comparable outcomes to the current 510(k) review process. Based on these initial results, FDA is continuing to explore information gathered during the Excellence Appraisal process (e.g., software validation) and alternative approaches, such as product demonstrations (which currently are not part of a traditional review process).

Real-World Performance.  FDA reports that it continues to work with pilot participants to outline the framework and mechanics for collecting Real-World Performance data.  FDA is exploring remote access to company data once the product is on the market, as well as leveraging performance data available from other external sources.

What’s Next?

The Agency seems to be years from implementing—or even beta-testing—a Pre-Certification program.  Substantial work appears to be needed in each of the program’s key components, and the Agency plans on engaging stakeholders to explore approaches and methodologies for certain components.

The update shows, however, that a new regulatory approach to SaMD continues to remain a priority for the FDA, even during pressures related to COVID-19.  Critics of the Pre-Cert Program argue that too much time has been spent on the program without a clear path for the specific regulations and authorities that the FDA will need to adopt and actually implement the Pre-Cert path.  Others would instead like to see more development and commentary from the FDA on its framework for reviewing Artificial Intelligence / Machine Learning software.

An updated Pilot Program Frequently Asked Questions (FAQs) can be found on FDA’s website.