The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has issued a final version of the guidance dedicated to the multiple function device products.
Regulatory Background
The regulatory framework to be applied for a medical product mostly depends on the functions of the product in question. Actually, the presence of the particular functions impacts the final determination of whether the medical product should be treated as a medical device or not. Such an approach has been initially implemented by the section 520(o) of the Food, Drug, and Cosmetic (FD&C) Act stating that the impact of the software non-device function should be assessed by the FDA in the course of assessment covering the device function. According to the position of the Agency, the same approach could be used in case of any other multiple function device products.
The guidance contains the definitions of the main terms used in the policy on multiple function device products.
- “Multiple function device product” is a product that has at least one function falling within the medical devices regulatory framework (device function), and at least one other function.
- “Function” – a distinct intended or subset of the intended purpose of the product. It is important to mention that the «distinct purpose of the product» should not be treated as a synonym to the «primary intended purpose» as one of the core concepts of the medical devices regulatory framework.
- “Other function” is the one that falls outside the scope of medical device definition, or is subject to any of exemptions.
- “Device function-under-review” is the main function of the device the FDA assessment is focused on.
In particular, the present FDA guidance describes the situations when the scope of the assessment to be performed by the FDA covers not only the device function subject to the pre-market review, but also the impact of other functions. The document describes the main principles the approach to the multiple function device products should be based on.
Medical Device Functions: Regulatory Approach
According to the general rule, any function of the medical product that falls within the scope outlined in the medical device definition should be subject to special regulation and oversight. Thus, the risk-based approach should be applied. Existing regulation provides that medical devices should be subject to premarket review under one of the following frameworks:
- a 510(k) premarket notification,
- a De Novo classification request (a special approach to be applied in case of entirely new medical devices),
- a biological license application (BLA) that covers certain devices,
- an investigational device exemption (IDE), or
- a humanitarian device exemption (HDE).
Low-risk medical devices falling outside the scope of the aforementioned frameworks are exempt from premarket review. However, such devices are still subject to the general oversight performed by the FDA. In some cases, low-risk software is subject to exemption from the regulatory oversight (for example, general wellness apps).
In order to clarify the concept of multiple function device products, the Agency provides the following example: if a product is intended only to analyse data, it actually has only one function. At the same time, if the product is intended to store, transfer and analyse data, it should be deemed to have three functions and thus should be treated as a multiple function device product.
Besides the general description of the concept and definitions, the present FDA guidance also covers all important aspects related to the modifications made to multiple function device products (in the part of other functions), and post-market requirements.
Premarket Review of Multiple Function Device Products
As it was mentioned above, the FDA applies a similar approach for both software-based and hardware-based products. The FDA contains the examples describing the particular ways such medical products would be assessed by the Agency in the course of premarket review. The Agency also emphasises that under certain conditions it will not review a device function subject to special regulation providing that such function is a part of a multiple function device product. In such cases, the authority will focus on the device function-under-review. Thus, the FDA will make its final decision regarding the approval of the device based on the results of the review conducted with regard to the main function of the device corresponding with its intended purpose.
According to the FDA guidance, the scope of the risk assessment performed by the medical device manufacturer should also describe the way other functions impact the safety and effectiveness of the device when used for the initial intended purpose. The Agency distinguishes two types of impact:
- Positive – other functions improve the safety and effectiveness of the main function, and
- Negative – other functions could impact negatively the main function.
It is important to mention that the manufacturer shall describe the positive impact only if it is reflected in the labeling of the device (the Agency refers to the concept of «labelled positive impact» while the negative impact should be described in any case. However, under 21 CFR 820.30(g), the medical device manufacturer is obliged to provide the assessment of any impact irrespectively of its type.
Premarket Submission Recommendations for Multiple Function Device Products
The FDA guidance also contains certain recommendations to be considered by the medical device manufacturers when preparing a pre-market submission. At the same time, the Agency emphasizes that additional device-specific requirements could be applied in case if it will be reasonably necessary due to the nature of the device and its features.
- Separation in design and implementation of the device function. The Agency recommends to separate the device function-under-review from other functions of the device in order to reduce potential risks associated with the other functions. The medical device manufacturer should also duly document all the measures taken to implement this recommendation. In most of the cases, such measures should be initially introduced at the design stage. This becomes especially important in the context of cyber-security risks.
- Impact of other functions. According to the guidance, the manufacturer shall evaluate the role of their functions, any limitations associated thereto, and also to take special measures (including the implementation of the appropriate technical solutions) to ensure that the impact caused to the device function-under-review would be reduced to the lowest extent possible.
The Agency also describes the information to be included into the pre-market submission for multiple function device products. First of all, when preparing for application, the medical device manufacturer should validate properly the design of the device in question and perform the impact assessment. Besides the general requirements applicable for any pre-market submissions, the manufacturers shall consider the following:
- The indications for use should only cover the device function-under-review, or the main function of the device.
- The description of the device should cover all its functions and the way they could impact the safety and performance of the device.
- The labeling of such devices should contain an appropriate description of other functions.
- The architecture and design document should be also provided to the authority to be used in the course of application review.
- The scope of the device hazard analysis should also cover the risks caused by other functions and the way they could impact the main function of the device.
- The submission should also include such elements as «Requirements and specifications», «Performance testing» and «Submission summary».
Summarizing the information provided here above, the FDA guidance on multiple function device products describes the approach utilized by the Agency when reviewing the pre-market submissions, and also provides medical device manufacturers with the important recommendations to be considered.
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