Coverage of the FDA Workshop on AI / ML Medical Devices – Part 2: Recent FDA Initiatives in Digital Health | Mintz – Perspectives on Healthcare
In our last article, we gave a brief historical review of the FDA’s approach to regulating medical device software and found that there was little distinction from the agency’s approach in material devices. Recently, however, the FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems (including its own internal data systems) and changing the way that The agency manages pre-market reviews and compliance activities for software such as a medical device (SaMD) and manufacturers of SaMD. In this article, we’ll review the highlights of the FDA’s digital health improvement over the past few years and take a quick look at the agenda for the Device Transparency Workshop. AI / ML compatible medical devices scheduled for October 14, 2021.
AI / ML based software
Some of the more recent FDA initiatives, and most relevant for the next workshop, relate to AI / ML-based SaMD regulation. In particular, on April 2, 2019, the FDA released a discussion paper titled Proposed regulatory framework for modifications to software based on artificial intelligence / machine learning as a medical device(SPS), Algorithm Change Protocols (ACP), and real-world performance monitoring. The discussion paper posed several questions to assess stakeholder reactions to the proposed framework, including transparency and real-world performance monitoring of AI / ML-based SaMD. In October 2020, the Agency hosted a meeting of the Patient Engagement Advisory Committee (PEAC) dedicated to AI / ML-based devices to better understand patients about the factors that influence their confidence in these technologies. .
Then, on January 12, 2021, the FDA released the Artificial intelligence and machine learning (AI / ML) software as a blueprint for medical devices (Action Plan), which responded to stakeholder comments on the discussion paper and outlined the agency’s planned next steps to develop greater surveillance of AI / ML-based SaMD. The action plan expressly includes the upcoming AI / ML-based SaMD transparency workshop as the next step in advancing a patient-centered approach to the development and regulation of such devices. According to the action plan, the FDA plans to discuss lessons learned from the CAPP meeting and solicit input from the wider community on how device labeling promotes transparency for users during the process. this week’s workshop.
In 2017, the FDA announced the launch of its software pre-certification (or pre-certification) pilot program, kicking off the formal development and agency assessment of a new regulatory approach that it says the agency, will promote SaMD innovation while guaranteeing safety and efficiency. In short, as part of Pre-Cert, the FDA performs an Excellence Assessment to assess the organizational practices and quality system of a SaMD manufacturer to determine if a manufacturer is eligible for pre-certification. Once pre-certified, the manufacturer is eligible for a streamlined review of new products or modifications to existing products and in some cases may bypass the pre-market review altogether.
The promise of the Pre-Cert program is that it will focus regulatory review on the manufacturer and their practices to ensure product quality rather than reviewing every new product and modification. This approach would certainly solve some of the problems with the FDA’s traditional approach to software regulation that we described in our previous article.
The Pre-Cert program is still in a pilot phase with nine participating manufacturers, and it may be years before SaMD manufacturers can apply for Pre-Cert status. The FDA website for the Pre-Cert program can be found here. In addition, you can find our previous observations on the program here and here.
Center of excellence in digital health
In September 2020, the FDA launched the Center of Excellence in Digital Health (DHCoE) to “provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public and the workforce. of the FDA â. DHCoE is currently leading FDA regulatory efforts regarding cybersecurity, the pilot pre-certification program, AI / ML-based SaMD, and wireless medical devices. The FDA’s concentration of resources in DHCoE is likely to significantly improve regulatory policies and agency rule making relating to new developments in software and digital technology.
You can find the FDA’s description of DHCoE here.
The public workshop will take place on Thursday, October 14 and begin at 10:00 a.m. with opening remarks from Nooshin Kiarashi (Digital Health Engineer, Senior Examiner, Office of In Vitro Diagnostics and Radiological Health), Jeff Shuren (Director, Center of Devices and Radiological Health), Bakul Patel (Director, Center of Excellence in Digital Health) and Matthew Diamond (Chief Medical Officer, Center of Excellence in Digital Health). At 10:30 am, there will be presentations and a round table dealing with two questions:
- “What does transparency mean for the various stakeholders of medical devices compatible with AI / ML?” “
- “What information about AI / ML compatible medical devices is important for each stakeholder to establish the safety and efficacy of these products?” “
Following the lunch break, there will be a 50 minute public comment session, during which registrants who have requested the floor can provide brief comments on the topic of AI / ML-based SaMD transparency. Finally, at 1:30 p.m. there will be another series of presentations and a panel discussion on the following question:
- “What are the current and possible ways to promote transparency of AI / ML compatible medical devices for users?” What practices do stakeholders see for information sharing, including labeling? What are the important areas for future development? “
In this article, we have provided a brief overview of recent FDA actions to develop new digital health programs and regulatory processes. Next week, we’ll share our comments and takeaways from the AI ââ/ ML-Based Medical Device Transparency Workshop.
As a reminder, you can register to attend the workshop by completing the registration form before 4 p.m. on Wednesday, October 13.