The new article highlights the aspects related to the changes to the design of a medical device and the potential impact thereof.

SFDA Guidance on Clinical Trials: Overview

The Saudi Food and Drug Administration (SFDA), a county’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the changes to Medical Device Marketing Approval (MDMA), a prerequisite for a medical device to be allowed for marketing and use in the country. The document provides additional clarifications regarding the regulatory requirements to be applied in case of significant and non-significant changes, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. 

In particular, the document describes in detail the approach to be applied with respect to different types of changes based on the impact they could have on the device’s safety and performance.

Significant Changes

First of all, the document outlines the scope of changes to the design that will be deemed significant. According to the guidance, such changes include:

  1. Changes in the intended use/intended users. For instance, should the manufacturer decide to expand the intended use of the device to include the claims not covered by the initial application for marketing approval, such changes will be considered significant. The same approach should be applied in case of adding a new type of user. As explained by the authority, in such a case, a medical device manufacturer will have to conduct an additional risk-based assessment in order to identify whether these changes are expected to impact the safety and proper performance of the device due to it being used by other user groups potentially having less training. 
  2. Changes impacting the risk management file of the product. In particular, any modification to an existing product introducing a new hazard will be considered significant. According to the document, this includes changes that adversely affect the probability, severity, or detectability of harm or consequences that were not previously documented by the manufacturer in the risk file. 
  3. Changes to the materials used, including changes to chemical composition or formulations could potentially impact the safety of the product or its characteristics. This category also covers changes to the source of materials used. In the case of the products containing medicines, changes thereto (quantity or type) would also constitute significant changes. 
  4. Changes to packaging or storage. This category applies to any change that affects the sterile barrier integrity of a product or its performance after storage, shelf life, or changing to the storage requirements, and also includes changes to the packaging material or method. 
  5. Changes in sterilization. The additional category describes changes to sterilization methods used and changes to subcontractors involved in the process. The authority also mentions that supplying non-sterile devices in a sterile condition would also be considered a significant change. 
  6. Changes in the control mechanism: as explained by the SFDA, changes to the control mechanism would most probably be considered significant as they are affecting the safety and performance of the product. 
  7. Changes to the operating principle would also be considered significant for both general and in vitro diagnostic (IVD) medical devices. 
  8. Changes of energy type. According to the document, changing the device’s energy input and/or output is considered a significant change. 
  9. Changes to the design specifications of the device, including the ones relates to  its dimensions, software used, or communication type would also be considered significant. Thus, when incorporating such changes, a medical device manufacturer would have to conduct a rigorous assessment of the effect such changes would have, and also update the respective risk management file to make sure the new risks identified are duly addressed and mitigated, ensuring the safety and proper performance of the device. 
  10. Changes to the human factors of the patient or user interface. The authority pays special attention to the changes related to the way the interaction between the product and the user takes place. This category covers changes to such elements as displays, controls, and packaging. According to the document, the relevant aspects should also be subject to a rigorous evaluation to be conducted by the manufacturer in order to assess the impact on the safety and effectiveness of the product such changes could have. 
  11. Changes to the operation environment. The SFDA also mentions that in case the device is now expected to be used in an entirely new environment, the risks associated with the device should be reassessed based on the specifics of the new use environment and relevant factors. The latter include inter alia, the following ones:
    • Temperatures and humidity that might affect device operation;
    • Noises that might drown out the sound of auditory alarms;
    • Exposure to water, soils, or light that might affect device operation;
    • Presence of other devices or equipment that may cause electromagnetic interference;
    • Possible use in MRI.
  12. Changes that require new clinical data to be provided to demonstrate the proper performance and safety of a modified product.
  13. Changes to the technology, engineering, performance, or materials of an IVD.
  14. Changes to components of the device or accessories thereto, provided such changes are significantly affecting the safety or performance of the device.

Non-significant Changes

Apart from the above, the authority also outlines the scope of changes that are not considered to be significant. According to the document, they would be the ones that do not have an impact on the design or the intended purpose of the device. 

In summary, the present SFDA guidance describes in detail the approach to be applied when determining the regulatory nature of changes to the design of a medical device allowed for marketing and use in the country. The document highlights the key points to be taken into consideration by medical device manufacturers and also emphasizes the importance of assessing the way the proposed changes are expected to affect the safety and effectiveness of the device in question.

Documentation Requirement

As it was mentioned before, it is important to ensure the monitoring activities related to the clinical investigation are duly documented. According to the relevant guidance, this should include the indication of the date when the activities took place, the names of the individuals involved, the summary, as well as the details of any noncompliances identified together with the information on actions taken in this respect. The level of detail should be sufficient for the authority to be able to verify whether the activities conducted are in line with the monitoring plan. The authority also mentions that monitoring activities to be documented should include on-site and remote monitoring of clinical sites and centralized monitoring across clinical sites. 

In summary, the present FDA guidance outlines the main elements to be included in a monitoring plan and provides additional clarifications in this respect. Apart from that, the document contains recommendations regarding the follow-up and documentation requirements to be followed in the course of a clinical investigation. 

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