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:
FDA intends to issue a draft guidance for public comments in 2021. This draft guidance will include a proposal of what should be included in an SPS and ACP to support the safety and effectiveness of Artificial Intelligence and Machine Learning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.
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.
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.
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.
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.
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 order for a device to be included in STeP, it:
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”:
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