- The FDA is moving quickly to ensure the development of a safe and effective artificial intelligence ecosystem in healthcare by releasing new documents intended to offer guidance to the health IT community.
The agency has published a new Software Precertification (Pre-Cert) Pilot Program working model test plan and a regulatory framework explaining how it plans to regulate the next generation of digital health devices.
Together, the documents represent the FDA’s vision for a voluntary model to monitor and regulate innovative clinical decision support and patient-facing technologies, particularly those that leverage artificial intelligence and machine learning to support decision-making.
“Software is increasingly used in healthcare to treat and diagnose conditions and diseases, aid clinical decision making, and manage patient care,” the FDA stated.
“Historically, healthcare has been slow to implement technology tools that have transformed other areas of commerce and daily life. One factor that has been cited, among many, is the regulation that accompanies medical products. But momentum toward a digital future in healthcare is advancing.”
The agency plans to exchange its traditional regulatory approaches for a model that offers more flexibility and faster, iterative review processes to accommodate the realities of the software development market and the fast-paced advancement of AI and machine learning.
“Software products offer unique opportunities, such as addressing malfunctions quickly and efficiently to reduce adverse events, understanding and capturing patient performance outside of the clinical setting, and enabling patient engagement,” the agency noted.
“Unlike manufacturers of hardware devices who modify their products every few months to years, developers of software modify their products in response to real-world performance and user feedback every few weeks to months.”
Taking a more agile approach to regulation is necessary to support innovation while maintaining a high degree of safety and security for patients, the report continued.
“It is important for public health to address these distinctive aspects of digital health technology – its clinical promise, unique user interface, ability to facilitate patient engagement with the developer, and compressed commercial cycle of new product introductions – while ensuring that existing standards of safety and effectiveness are met or exceeded,” the FDA said.
During 2019, the FDA will test the new model’s effectiveness through the Pre-Cert Pilot Program.
“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 (CQOE) and are committed to monitoring real-world performance while assuring that these devices are safe and effective,” the FDA explained.
“In developing Version 1.0 of the program, the current focus is to establish processes for software as medical device (SaMD) technologies, which may include software functions that use artificial intelligence and machine learning algorithms.”
The model would be implemented under the De Novo classification process, which is intended to create a speedy but thorough process for approving lower-risk medical devices.
Participants would be able to request an Excellence Appraisal, which will allow developers to demonstrate their commitment to safety and innovation and receive a “pre-check” approval to support future applications for FDA clearance.
“The Software Pre-Cert Program is intended to build stakeholder confidence that participating organizations have demonstrated capabilities to build, test, monitor, and proactively maintain and improve the safety, efficacy, performance, and security of their medical device software products, so that they meet or exceed existing FDA standards of safety and effectiveness,” the FDA said.
During pre-certification, organizations would be evaluated across five major domains: product quality, patient safety, clinical responsibility, cybersecurity responsibility, and proactive culture.
“Organizations that produce safer and more effective device software products not only ‘do the right things,’ but they also ‘do the things right’ based on evidence that informs better decision-making,” the FDA said.
“While governance and processes may differ, these organizations tend to follow a common set of goals, objectives, and approaches across the product lifecycle. FDA believes organizations committed to these principles can show, through their existing processes and activities, a demonstration of the Excellence Principles for the purposes of precertification.”
Once the developer has been assessed for the presence of a high-quality culture, the FDA will apply additional evaluation processes targeted to the SaMD in question.
If the device meets the criteria included in the FDA’s streamlined review processes, it will be approved for marketing and remain subject to ongoing real-world performance evaluations.
Continuous monitoring for safety and effectiveness falls in line with the FDA’s total lifecycle approach to overseeing the health IT ecosystem, the agency said.
As the pilot phase unfolds during 2019, the FDA will seek input from industry about the effectiveness of the strategy.
“Through development of tools, techniques, and processes, we anticipate the appraisal elements would be further refined with the goal of providing increased precision, accuracy, and confidence in the appraisal methods and demonstration of excellence in product development,”
Interested stakeholders are encouraged to offer comments on the Pre-Cert working model until the public comment period closes on March 8, 2019.
The FDA is also offering a user session on February 7, 2019, to answer questions from the development community about the model and regulatory framework. More information about the event is available here.
“FDA intends to consider stakeholder comments by reviewing the public docket approximately every two weeks, and to incorporate comments, as appropriate, in future versions of the working model,” the agency concluded. “We encourage the public to provide feedback early and often.”