On June 14th, 2023, the FDA released its final guidance on premarket submissions for software as a medical device (SaMD), officially titled Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff. This 2023 guidance updates the previous document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, released in 2005.
This 2023 version includes several changes that medical technology and software development companies need to be aware of before submitting software products to the FDA for approval. Below, we look at these important changes and what your company can do to prepare for the submission process.
Differences Between 2023 Release and 2005 Guidance
Given how much technology has evolved in the 18 years since the first device software guidance was published, it’s not surprising that this latest version includes a host of changes. Most notably, this guidance takes a risk-based approach to what documentation is needed. The new guidance also takes into account new legislation concerning SaMD and offers additional recommendations based on the software or device in question.
Risk-Based Approach
In the original 2005 guidance, documentation requirements were based on which Level of Concern category the software fell into. Based on the potential risk to the user, the software was categorized as Major, Moderate, or Minor.
These categories have been eliminated in the latest version of the guidance. Instead, software falls into one of two submission categories: Basic or Enhanced.
Enhanced documentation is required for device software that poses a greater risk to the user. This risk definition aligns with the previous definition of Major Level of Concern. That is, any software that could result in death or serious injury. However, the definition of this new category emphasizes that risk determination should precede the consideration of risk controls.
Any software that does not meet the definition of high risk requires only Basic documentation. This category includes software that fell into the previous definitions of Moderate and Minor Levels of Concern. This change effectively simplifies the documentation process for device software that is unlikely to cause death or injury.
Considerations of New Legislation
Many legislative changes have occurred since 2005 concerning medical devices and software. These changes are reflected in this newest guidance.
Most notably, certain software functions have been removed from the guidance under the 21st Century Cures Act, which redefined medical devices and removed these functions from that designation.
The 2023 guidance also takes into account Predetermined Change Control Plans. This change stems from the FDA’s draft guidance released in March on authorization pathways for software containing AI and machine learning. Because this software is continuously learning and improving, a preauthorization process for expected software evolution is necessary.
Additional Guidance Recommendations
The 2023 Guidance on Premarket Submissions for Device Software Functions includes a list of guidance documents considered a “subset of FDA guidances with digital health content relevant to premarket software documentation activities.”
These include:
- Multiple Function Device Products: Policy and Considerations
- Off-The-Shelf Software Use in Medical Devices
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices
- General Principles of Software Validation
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software
- Applying Human Factors and Usability Engineering to Medical Devices
Additionally, the 2023 guidance includes a short list of international software and medical technology standards that influenced its content. These include:
- ISO 14971: Medical devices – Applications of risk management to medical devices
- IEC 62304: Medical Device Software – Software Life Cycle Processes
- SW91: Classification of defects in health software
Understanding Premarket Submissions for Device Software Functions
Understanding FDA premarket submission requirements, such as those outlined in the FDA’s guidance on Premarket Submissions for Device Software Functions, is crucial for medical device companies.
Adhering to FDA regulations is required for MedTech companies to legally bring products to market. Failure to comply with requirements can result in significant financial penalties, recalls, and reputational damage. Rigorous premarket submissions help the FDA evaluate the safety and effectiveness of device software before it’s available to patients and healthcare providers. Understanding and fulfilling these requirements ensures that only safe and effective devices reach the market, reducing the potential for patient harm.
Familiarity with the FDA’s premarket submission requirements allows companies to navigate the regulatory process more efficiently. A clear understanding of submissions, required documentation, and review timelines helps streamline the approval process, enabling faster market rollout while saving time and money.
If your medical device or software company is struggling to navigate this complex landscape or to understand the premarket submission requirements for your software products, Sequenex is here to help. Connect with us today to learn how we can help with the approval process for your SaMD or medical device.
