The FDA outlines its approach to modifications for software as a medical device (SaMD), emphasizing a risk-based framework for evaluating changes post-market authorization. Manufacturers are encouraged to have a pre-specifications and algorithm change control plan in place, allowing certain modifications to be documented without pre-market submission. The FDA is seeking feedback on how to handle changes outside approved plans and the focused review process for such modifications.

1. FDA’s Approach to SaMD Modifications
By: Nikita Angane
As part of our blog series on Artificial Intelligence and Machine Learning Medical Devices, this
time we will discuss the FDA’s take on how modifications made to the software after its initial
review will be addressed within the SaMD pre-specifications and Algorithm Change Protocol
submitted by the manufacturer to the FDA as part of the predetermined change control plan.
For reference, you can read the following previous blogs on AI/ML devices:
ARTIFICIAL INTELLIGENCE & MACHINE LEARNING TECHNOLOGIES
QUALITY SYSTEMS AND GOOD MACHINE LEARNING PRACTICES
INITIAL PREMARKET ASSURANCE OF SAFETY AND EFFECTIVENESS FOR AI/ML
MEDICAL DEVICES
After a SaMD receives market authorization from the FDA, any modifications to its software
would have to go through a pre-market review as outlined in the software modification guidance-
Deciding when to submit a 510(k) for a software change to an existing device.
Due to the continuous learning and adaptive nature of AI/ML devices, these capabilities would
be considered modifications. The FDA’s new guidance allows for a risk-based approach to tackle
such modifications without having companies worry about submitting a pre-market submission
every time the device modifies its algorithm based on real-world data.
A SaMD device manufacturer or developer is expected to evaluate the modifications based on
the risks to the patients as outlined in the software modifications guidance, perform a risk
assessment and perform appropriate risk mitigation activities.
The current software guidance results in either:
 A new 510(k) for the proposed modification
 Documentation of the modification in the risk management file
According to the FDA’s new guidance, if the AI/ML developer has a SaMD pre-specifications
and an Algorithm Change control Plan approved as part of the predetermined change control
plan, and if the changes or modifications to the device are within the bounds of the SPS and the
ACP, then the manufacturer can simply document the change within the change history/change
control program devised within their quality system with appropriate records.i

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In cases where it is anticipated that the modifications may change the intended use, beyond the
intended use for which the SaMD was previously authorized, FDA will conduct a ‘focused
review’ of the SPS and ACP that includes the said intended use modification in its plan.
FDA suggests that manufacturers engage with them on SPS and ACP for a particular SaMD.
Some options include:i
 Contact the appropriate review division of the FDA to determine if the modification fits
the current SPS and ACP.
 Submit a pre-sub for a discussion with the FDA on the modification.
 Submit a premarket submission or application of the modification to the SPS and ACP.
FDA is accepting feedback on this proposed guidance on the public docket. FDA seeks specific
feedback on the following items:i
How should FDA handle changes outside of the approved SPS and ACP?
How should FDA go about conducting the proposed focused review of the SPS and the ACP and
what content should it include?
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:
https://www.regulations.gov/comment?D=FDA-2019-N-1185-0001
For any other questions that you may have about the proposed regulatory framework, please
contact us at 248-987-4497 or info@emmainternational.com.
i
FDA (Apr 2019) Artificial Intelligenceand MachineLearningin Software as a Medical Device retrieved on 04-10-
2019 from
https://www.fda.gov/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/ucm634612.htm