The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks.


MHRA Guidance on Medical Software and Applications

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 the use of off-the-shelf (OTS) software in medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith.

At the same time, provisions of the guidance are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed upon with the authority in advance. 

The scope of the guidance covers, inter alia, the aspects related to the approach to be applied with respect to OTS software when submitting marketing applications. In order to assist medical device manufacturers and other parties involved, the document provides recommendations based on the applicable regulatory mechanisms and pathways used to place new products on the market.


Master Files for Devices (MAFs)

First, the authority mentions that much of the information regarding the development and validation of OTS software may not be readily available to medical device manufacturers who wish to use the OTS software as a device component.

Thus, software developers intended to make their products available for use in medical devices while ensuring the confidentiality of the software development and validation could provide all the information related to the product directly to the authority. In such a case, this information will not be disclosed to other parties involved in operations with OTS software used in medical devices, including end-medical device manufacturers.

OTS Software Change Requirements

In accordance with the applicable regulatory requirements, in certain cases, changes to the OTS software used in a medical device would require a new 510(k) submission due to the significance of the impact such changes would have. Under the general rule, the conditions under which a new or changed medical device, including OTS software, will require a new 510(k) are the same as for a device not involving OTS software.

As further explained by the authority, the final decision on whether a new 510(k) submission is required or not should be based on numerous important factors, such as the intended use of the device, the functionality of the OTS software it employs, as well as the risks associated with its use and whether they are properly mitigated. In this respect, the authority also refers to separate guidance documents named “Deciding when to submit a 510(k) for a change to an existing device” and “Deciding when to submit a 510(k) for a software change to an existing device” for additional clarifications.

Investigational Device Exemptions

The document also describes the approach to be applied with respect to Investigational Device Exemptions (IDE) related to medical devices incorporating OTS software and changes thereto. Under the general rule, the IDE-related requirements remain the same irrespective of whether the product in question incorporates the OTS software, or even if the OTS software constitutes the entire product.

As further explained by the FDA, the conditions that would require submission of an IDE are specified in Section 21 CFR 812 and generally include changes to OTS software during an IDE study that would affect the patient population for which the medical device is intended; conditions of use of the device (including those recommended or suggested in the labeling or advertising; the probable benefit from the use of the device weighed against any probable injury or illness for such use); or the reliability of the medical device. 

The FDA also mentions that sometimes OTS software could be subject to additional testing in the course of a clinical investigation. Should it be carried out, the respective IDE requirements should be followed to the letter. In the case of non-significant risk medical devices, it would be sufficient to have informed consent from the study participant and approval from the respective institutional review board (IRB). At the same time, in the case of significant risk studies, an IDE submission would also require a user testing protocol to be included.

This would apply, for instance, in the case of beta testing of radiation treatment software incorporating OTS software modules carried out in accordance with the applicable IDE requirements. In this respect, the authority further refers to a guidance document dedicated to significant risk and nonsignificant risk medical device studies for additional clarifications. 

Premarket Approval 

The scope of the guidance also covers aspects related to premarket approval (PMA) applications under 21 CFR 814 in the context of OTS software used in medical devices. Under the general rule, when a manufacturer submits a PMA submission for a medical device, there must be valid scientific evidence (including clinical evidence, if needed) to support a reasonable assurance of the safety and effectiveness of the device. The authority further explains that such OTS software should be subject to a rigorous evaluation in the context of a medical device in general, paying special attention to the role OTS software has as well as the risks associated therewith. 


The document also provides recommendations related to labeling for medical devices incorporating OTS software. In particular, the authority expects medical device manufacturers to include indications of software versions in user manuals accompanying the device when it is placed on the market. 

In summary, the present FDA guidance highlights the most important aspects associated with OTS software used in medical devices in the context of marketing applications. The document describes additional considerations related to the main frameworks, such as 510(k) or PMA. 

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