The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to deciding whether the software changes to a medical device already placed on the market require a new 510(k) application to be submitted. The present article describes additional factors to be taken into consideration by the medical device manufacturer. 

First, the authority mentions that it is impossible to cover all potential changes the software used in medical devices could be subject to, so the present guidance only describes the general approach to be applied and provides recommendations to be followed in order to ensure compliance with the applicable regulatory requirements. In particular, the approach suggested by the authority is based on the rigorous assessment of the impact caused by the software changes in question on the safety and performance of the device. However, in certain cases, even changes that are not initially intended to impact operations of the device could result in significant changes in how the device will operate once these changes are implemented. Hence, in order to ensure the safety of patients and any other persons using the device, as well as its effectiveness when used for the intended purpose, the medical device manufacturer should assess the potential impact such changes could have.

Another important point the Agency pays special attention to relates to the structure of the software. It is stated that if the software in question consists of several modules, it is less likely that minor changes will have an impact on the overall performance of the software. At the same time, if the software in question does not have a clear structure, such changes could significantly impact the safety and performance of the device the software operates.

Thus, the part of the FDA guidance described herein covers the aspects related to “code maintenance” and “infrastructure” changes. Additionally, the authority encourages medical device manufacturers (software developers) to contact relevant divisions of the FDA to discuss planned changes in detail.

Common Software Change Types 

In order to assist medical device manufacturers in applying the policy for software changes to existing medical devices, the FDA provides an overview of possible changes and outlines the main change types. 

According to the document, the changes could be:

  • Infrastructure changes, which stands for modifications made to the software support system. Such changes include changes to the programming languages used or drivers. In this regard, the authority emphasizes the importance of taking into consideration the complexity of the changes in question. For instance, in the case of changes to the programming languages the software is based on, the difference in syntax should be considered. If such changes are significant, a new 510(k) application would probably be necessary. The same approach should be applied in the case of any other changes similar in nature. The authority mentions that it is also important to understand the reasons behind the changes made in order to be able to assess the potential impact such changes would have on the safety of the device in question and its operations. 
  • Architecture changes refer to modifications to the overall structure of the software. For instance, changes of this type would include changes made to support a new hardware platform. Since such changes would cause a significant impact on the operations of the software, they will require the submission of a new 510(k) application. 
  • Code algorithm is defined as modifications made to an algorithm that directly impact or contribute to the device’s intended use. For instance, this applies to changes to a detection module or alarm algorithms. In this regard, the authority states that a complete rewrite of the function would require an additional assessment to evaluate the actual impact it will cause and most probably would require a new 510(k) to be submitted by the medical device manufacture. 
  • Clarification of Requirements – No Change to Functionality stands for changes made to clarify software requirements after a product has received premarket clearance. In most cases, such software changes do not require a new 510(k) to be submitted. 
  • Cosmetic Changes – No Change to Functionality refers to changes made to the appearance of the device that do not impact the clinical use of the device. This covers various changes (even significant ones) intended solely to modify the visual appearance of the software (e.g., adding a new logo). 
  • Reengineering and refactoring. The first is defined as an examination and alteration of software to reconstitute it in a new form and includes the subsequent implementation of the new form. According to the guidance, this could take place when it is necessary to replace outdated software. The second term refers to a disciplined technique for restricting a software program’s internal structure without changing its clinical performance specification. Usually, it could be performed in order to improve the internal structure of the software. Under the general rule, the determination of whether a new 510(k) submission is required should be based on an assessment of the potential impact such changes would cause to the safety and effectiveness of the software in question. So, if changes include significant modifications to the software, they will be more likely to require a new 510(k) submission. It is also stated that reengineering is usually associated with more significant changes than refactoring. 

Software Modification Examples 

Apart from general information about types of software changes, the FDA guidance also provides examples of software modifications and describes how they should be treated under the current regulatory framework. The Agency additionally emphasizes that the examples provided are generalized and do not take into account all specific aspects that could be important and should be considered by the medical device manufacturer (software developer) when determining whether the particular software changes to an existing medical device require a new 510(k) submission. 

In summary, the present FDA guidance describes in detail the approach to be applied with regard to software changes and regulatory requirements associated thereto. According to the recommendations provided in the guidance, irrespectively of the nature of the changes, the decision of the manufacturer on whether to submit a new 510(k) or not should be based on a rigorous assessment of the impact the software changes in question would cause to the safety and performance of the software. Additionally, the manufacturer shall evaluate the significance of such changes in order to determine the possibility of unplanned impact the changes could cause on the normal operations of the product. 


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