Artificial Intelligence & Machine Learning Technologies

by | Apr 19, 2019 | AI, Cybersecurity, FDA, Medical Devices, Quality Systems

On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191. This proposed regulatory framework is another strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry.

The current premarket pathways, premarket notification- 510(k), De Novo classification, or premarket approval, and software modification guidance, “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”2, work well for algorithms that are “locked”, but do not embrace the iterative improvement power of AI / ML-based Software as Medical Device (SaMD). Due to this, FDA’s proposed regulatory framework takes on a Total Product Lifecycle (TPLC) approach which, in theory, will allow what the, cleared or approved, SaMD learns from real-world feedback to be incorporated into the software without an additional FDA review – so long as the risk requirements are met3.

This TPLC approach to evaluate AI / ML-based SaMD is based on four general principles:

  1. “Establish clear expectations on quality systems and Good Machine Learning Practices (GMLP);
  2. Conduct premarket review for those SaMD that require premarket submission to demonstrate reasonable assurance of safety and effectiveness and establish clear expectations for manufacturers of AI / ML-based SaMD to continually manage patient risks throughout the lifecycle;
  3. Expect manufacturers to monitor the AI / ML device and incorporate a risk management approach and other approaches outlined in “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” Guidance in development, validation, and executions of the algorithm changes (SaMD Pre-Specifications and Algorithm Change Protocol); and
  4. Enable increased transparency to users and FDA using post-market real-world performance reporting for maintaining continued assurance of safety and effectiveness.”3

The TPLC premarket review is unlike any other premarket review FDA currently oversees. FDA is proposing SaMD developers to anticipate ways their AI / ML – based SaMD may learn and need modified and build them into a predetermined change control plan.

This predetermined change control plan would be required to have SaMD Pre-Specifications (SPS) based on what the algorithm would learn / improve upon and an Algorithm Change Protocol (ACP) to implement those improvements in a controlled manner managing risks to patients. FDA does acknowledge that the required SPS and ACP will mean each benefit and risk to the patient will have to be individually considered, which carries the potential to slow the approval of AI / ML-based SaMD3. However, will the benefit of not requiring additional FDA review for each change outweigh the potential for a slow process of getting to market?

The release of this new proposed regulatory framework promotes the idea that FDA is taking strides to focus on the integration of AI / ML -based SaMD potentially allowing the US health market to keep pace with other industries in the AI / ML space.

You can submit your suggestions or comments on FDA’s Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback using the following link:

For any other questions that you may have about the proposed regulatory framework, please contact us at 248-987-4497 or

1FDA (Apr 2019) Artificial Intelligence and Machine Learning in Software as a Medical Device retrieved on 04-10-2019 from

2FDA (Oct 2017) Deciding When to Submit a 510(k) for a Software Change to an Existing Device retrieved on 04-10-2019 from

3FDA (Jan 2019) Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback retrieved on 04-10-2019 from

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