Medical device industry representatives are pushing the Food and Drug Administration (FDA), the US regulating authority, to provide additional clarification regarding the framework that establishes the legal status of Clinical Decision Supporting (CDS) software.
Clinical Decision Supporting Software: Definition And Scope
Clinical decision support is a widely used term describing the technology utilized by users or healthcare facility personnel to get additional information processed in a specific way or provided when appropriate to use it for improvement of health care or therapy. The Federal Food, Drug, and Cosmetic Act covers the software providing “decision support for diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions” that actually constitutes CDS software. This software could also be described as various tools, such as automated reminders used by both professionals and users, special guidelines, summaries and reports covering data of patients, samples and templates of documents and other supplementary information. Thus, the scope of CDS is quite wide and there is no exhaustive list covering all possible examples of clinical decision supporting software.
In accordance with the amendments made by the Cures Act to the Food, Drug, and Cosmetics Act, in some cases CDS software should not be considered a device. In particular, it should be excluded if:
- It is not intended to process any signal or image received from IVD or signal acquisition system;
- Its purpose is to display, print or analyze any information related to the particular patient, or any medical information in general;
- It provides recommendations used by healthcare facility personnel (professionals) for diagnostic purposes, prevention or treatment;
- The information provided by such software plays a supplementary role while the healthcare professional makes his own independent decision taking into account the information provided by the software but avoiding relying solely on such information.
At the same time, the FDA distinguishes Device CDS and Non-Device CDS. According to the criteria provided by the FDA, it is a CDS if:
- It is not intended to acquire information, process or analyze it;
- It is intended to display, analyze or print information;
- It provides recommendations.
The aforementioned criteria meet some of the exclusion criteria introduced by the Cures Act described above. If the device meets all four criteria, it is Non-Device CDS while if it fails to meet the criteria on the intended purpose of providing recommendations (third criteria) and/or the criteria related to the independent decision-making process, it could be defined as a Device CDS. To be excluded from the device definition, it should be independent of the platform on which it operates.
FDA On CDS Software
To assist all parties involved, the FDA has already published the guidance dedicated to CDS software and the most important aspects associated with it. The document has been developed on the basis of existing regulations including the Food, Drug, and Cosmetic Act which is the principal act establishing the regulatory framework for medical devices and software with an intended medical purpose. In particular, the guidance describes the approach the Non-Device CDS in accordance with the Food, Drug, and Cosmetics Act. At the same time, the guidance also covers certain CDS excluded from the FD&C Act, intended to be used only by healthcare professionals.
The International Medical Device Regulators Forum (IMDRF), an international organization of national medical device regulating authorities, pays attention to the issues related to CDS software too. The IMDRF’s position regarding this issue has been expressed in the Framework “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” published in 2014. The document is intended to establish general principles and harmonized approaches to improve cooperation between all parties involved. The IMDRF additionally emphasizes on the following criteria:
- How the information received with the help of the software would be used, and decisions based on such information;
- The state of the patient’s health at the moment when the information provided by the software should be used
It is also important to mention that current draft guidance on CDS software implements the main principles provided by the IMDRF’s document, including the risk categorizations. The FDA utilizes both significance and state criteria, applying them in the following way:
- Depending on the significance of the information provided by the software, there are three categories:
- Informal Clinical Management – the software provides information on diagnosing or treating. This information should not be used immediately to take action or to provide accumulated information collected from one or several sources.
- Drive Clinical Management – the software provides information used to identify a disease or improve the safety and effectiveness of the treatment process. According to the Cures Act, the software of this type is not a CDS.
- Treat or Diagnose – the information provided by the device should be used to take immediate actions to identify the disease using sensors or provide treatment (for this purpose, the connection with another device could be performed). The software of this type also does not belong to CDS.
- Depending on the state of the particular healthcare situation or the specific conditions under which the software should be used, there are also three categories:
- Non-serious: when accurate information is important but not critical (including cases when medical intervention is not required).
- Serious: accurate information is important either to prevent the disease process or to avoid unnecessary medical intervention.
- Critical: accurate information is very important to prevent severe consequences or reduce the impact on public health, including situations when inaccurate information could result in the harm caused to a particular patient or the public in general.
The FDA is going to focus on higher risk Device CDS software in order to inform clinical management on serious and critical situations. At the same time, the Agency is not going to enforce compliance for lower risk devices.
CDS Software: Industry Concerns
The groups of industry representatives are seeking additional clarification regarding the guidance on CDS software already published by the FDA. The list of inquiries submitted by all parties involved includes, among others, the following points of attention:
- To further clarify the particular types of CDS software that are subject to FDA supervision as well as those exempted from the oversight,
- To provide additional visual materials to simplify the understanding of the status of the product, including the information necessary to understand whether the software is a Non-Device CDS or not,
- To provide the FDA’s interpretation of the definitions “treat or diagnose”, “drive”, “inform” in the context of a three-level classification system based on significance and to provide additional examples of the software that belongs to each category,
- To clarify the way the existing regulations should be applied to the software used during clinical trials, e.g. in companion diagnostic studies.
Numerous requests filed by the industry representatives confirm that information provided by the FDA in the aforementioned guidance is not sufficient for parties operating with software intended for medical purposes in general and CDS software, in particular, to deal with all regulatory issues arising. This is why additional clarification is necessary.
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