The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan:
This Artificial Intelligence and Machine Learning AI/ML based Software as a Medical Device Action Plan was developed in direct response to the stakeholder feedback, including hundreds of public comments, and it builds on the Agency’s longstanding commitment to support innovative work in the regulation of medical device software and other digital health technologies.
The Plan outlines five actions the FDA intends to take, which include:
- Further developing the proposed regulatory framework, including issuing draft guidance on a predetermined change control plan;
FDA intends to issue a draft guidance for public comments in 2021. This draft guidance will include a proposal of what should be included in an SPS and ACP to support the safety and effectiveness of Artificial Intelligence and Machine Learning
AI/ML SaMD algorithms (SaMD Pre-Specifications (SPS) describe “what” aspects the manufacturer intends to change through learning, and the Algorithm Change Protocol (ACP) explains “how” the algorithm will learn and change while remaining safe and effective). Other areas of development will include refinement of the identification of types of modifications appropriate under the framework, and specifics on the focused review, including the process for submission/review and the content of a submission.
- Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
FDA will support the development of Good Machine Learning Practices, or GMLP, to describe a set of AI/ML best practices (e.g., data management, feature extraction, training, interpretability, evaluation and documentation) that are akin to good software engineering practices or quality system practices.
- Fostering a patient-centered approach, including device transparency to users;
FDA is committed to supporting a patient-centered approach including the need for a manufacturer’s transparency to users about the functioning of AI/ML-based devices to ensure that users understand the benefits, risks, and limitations of these devices.
- Developing methods to evaluate and improve machine learning algorithms;
FDA will support regulatory science efforts to develop methodology for the evaluation and improvement of machine learning algorithms, including for the identification and elimination of bias, and for the evaluation and promotion of algorithm robustness.
- Advancing real-world performance monitoring pilots;
FDA will advance real-world performance pilots in coordination with stakeholders and other FDA programs, to provide additional clarity on what a real-world evidence generation program could look like for AI/ML-based SaMD.
FDA publishes final guidance on its new Safer Technologies Program for Medical Devices (STeP)
The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions.
Similar to the Breakthrough Devices Program, STeP is comprised of two phases:
- In the first phase, interested sponsors formally request inclusion in STeP through a Q-submission
- The second phase encompasses actions to expedite the development of the device and review of subsequent regulatory submissions (e.g., pre-submissions, marketing submissions)
In order for a device to be included in STeP, it:
- should not be eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device; and
- should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for one or more of the following:
- reduction in the occurrence of a known serious adverse event,
- reduction in the occurrence of a known device failure mode,
- reduction in the occurrence of a known use-related hazard or use error,
- improvement in the safety of another device or intervention.
FDA updated the final guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”
The reason for the update is to include that a Q-submission is the appropriate mechanism for submission of requests for inclusion in STeP, as well as other minor updates.
Now Q-Submission program can be used for the submissions associated with the Safer Technologies Program (“STeP”) as described in FDA’s guidance entitled, “Safer Technologies Program for Medical Devices”:
- STeP Entrance Request: to request inclusion in the Safer Technologies Program.
- STeP Interaction Submission: to request feedback on device development and clinical protocols for devices previously included in STeP.
