FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles”

Operating room with monitor

Published:

June 26, 2024

Author Info:

Monica R. Montanez

Topics:

, ,

Related Services:

In 2021 Health Canada, the U.S Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified the 10 guiding principles for Good Machine Learning Practice (GMLP). GMLP supports the development of safe, effective, and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device performance.

On June 13, 2024, the FDA, Health Canada, and the MHRA jointly published the “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles | FDA.” This new publication has further identified guiding principles for transparency for machine-leaning-enabled medical devices (MLMDs).  These principles build upon the GMLP principles, especially:

  • Principle 7: Focus is placed on the performance of the human-AI team.
  • Principle 9: Users are provided with clear, essential information.

These guiding principles are favorably welcomed since there is still a need for recognized standards for GMLP and now the Transparency for MLMDs. There are several considerations to keep in mind when adopting and advancing good transparency practices.

Six guiding principles for transparency of MLMDs:

  1. Who: Relevant Audiences: Transparency is relevant to:
    • Those who use the device, such as healthcare professionals, patients, and caregivers.
    • Those who receive health care with the device, such as patients.
    • Additional parties, including those who make decisions about the device to support patient outcomes, such as support staff, administrators, payors, or governing bodies.
  2. Why: Motivation: Transparency supports:
    • Safe and effective use.
    • Patient-centered care.
    • Identification and evaluation of device risks and benefits.
    • Informed decision-making and risk management.
    • Device maintenance and detection of errors or performance degradation.
    • Health equity through identification of bias.
    • Increased fluency and confidence in MLMD use and/or increased adoption of the technology.
  3. What: Relevant Information: Enabling an understanding of the MLMD includes sharing relevant information on:
    • Device characterization and intended use.
    • How the device fits into healthcare workflow, including the intended impact on the judgment of a healthcare professional.
    • Device performance.
    • Device benefits and risks.
    • Product development and risk management activities across the lifecycle.
    • Logic of the model, when available.
    • Device limitations, including biases. Confidence intervals and data characterization gaps.
    • How safety and effectiveness are maintained across the lifecycle.
  4. Where: Placement of Information: Maximizing the utility of the software user interface can:
    • Make information more responsive.
    • Allow information to be personalized, adaptive, and reciprocal.
    • Address user needs through a variety of modalities.
  5. When: Timing of Communication: Timely communication can support successful transparency, such as:
    • Considering information needs at different stages of the total product lifecycle.
    • Providing notifications of device updates.
    • Providing targeted information when it’s needed in the workflow.
  6. How: Methods to Support Transparency: Human-centered design principles can support transparency.

Next Steps

The new discussion paper is open for feedback through the FDA public docket  https://www.regulations.gov/docket/FDA-2019-N-1185 or you can contact directly at:

 

NAMSA’s Insights

  • What also comes to mind when you hear the word “transparency”?

This comes in different names and flavors such as trustworthiness and explainability come to mind.

  • Why is transparency so important to the FDA?

These types of products are typically novel devices, and when communicating with the FDA in a pre-submission or marketing application they will insist on providing transparency in how the ML algorithm such as data sets and/or models are developed. They will not be able to respond to whether the regulatory pathway, preclinical, and clinical testing requirements are adequate or appropriate for your device. The key is understanding whether the design of the device meets the claimed indications for use. Having this understanding will help the FDA determine which regulation may be applicable to the device and/or the generation of new regulation and product code.

  • Why is transparency so important to Healthcare Providers (HCPs), Hospitals, and Payers?

NAMSA recommends engaging HCPs and payers early and regularly to provide proof (transparency) that the MLMD outcomes are worth paying. From a product development perspective, you want to ensure that the device design fits nicely into the healthcare workflow and Hospital IT systems.

 

How Can NAMSA Help?

NAMSA has experience working with medical device developers who make a wide variety of patient monitoring, disease management, Picture Archiving and Communication System (PACS) imaging, and other software-containing medical devices whose value and effectiveness can be enhanced through Mobile Health (mHealth) technology.

We provide regulatory and quality consulting services to organizations who design, produce, develop, supply, deploy, and use any of the following:

  • Software as a Medical Device (SaMD)
  • Mobile Medical Apps
  • Medical devices of all types with a particular focus on “active” devices and in vitro diagnostic (IVD) medical devices with or without software components or accessories
  • Clinical Decision Support and health analytical software
  • Software as a Service (SaaS) within the healthcare sector
  • Artificial Intelligence (AI), deep learning, machine learning, and big data algorithms

NAMSA’s Global Strategy Team is made up of highly skilled, cross-functional scientific and strategic consultants with technical expertise across the medical device development continuum. This group of industry experts collaborates with clients to develop effective market introduction and commercialization strategies for innovative medical device and drug-device technologies, which includes effective interactions with global regulatory agencies that lead to successful development outcomes.

If you are interested in speaking with us about regulatory strategies, please Contact Us, or learn more about our Regulatory Experts at namsa.com/subject-matter-experts.

Monica R. Montanez

Monica R. Montanez

Monica R. Montanez, MS, RAC, CQA currently serves as NAMSA's Principal Strategy Consultant. Monica has over twenty years’ experience in the medical device industry in Regulatory Affairs and Quality Assurance. Her primary focus is navigating the regulatory pathways for electro-mechanical and software driven medical devices worldwide. She has received clearance of many 510(k)s and approval of new indications for PMA device(s) of which 90% involved software. She has broad regulatory expertise in several areas of digital health, including: Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), mobile medical apps, clinical decision support software, telehealth, artificial intelligence, machine learning, interoperability, cybersecurity and human factors engineering, including wireless medical devices -radio frequency (RF), electromagnetic compatibility (EMC) and electromagnetic interference (EMI). While in industry, she assisted in the development of FDA 510(k) guidance and FDA Software guidance directly with FDA. Monica holds a Masters of Science (MS) degree in Regulatory Science (RS) from the University of Southern California (USC) School of Pharmacy. Currently. she holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Let’s Talk About Your Project

Ask a question or request a meeting with a NAMSA expert to discuss your specific project. We will follow up as quickly as possible. Also, please tell us how you heard about NAMSA.

    By choosing to submit your information to contact NAMSA, you are providing NAMSA consent to process and store your information on the NAMSA Network. At any time, you can submit a request to withdraw your consent for the use of information provided by you. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.