The SaMD industry is relatively new, so the FDA scrambles to keep up with its health and safety regulations. However, while these policies and regulations are still evolving, the FDA does regulate SaMD. If you’re in the software or medical device industry and want to know what to expect from the FDA, you’ve come to the right place.
What is SaMD?
SaMD stands for software as a medical device and refers to any piece of software developed for the purpose of use in the medical field. The International Medical Device Regulators Forum defines SaMD as any software intended for use in the medical field, capable of fulfilling its purpose without actually being part of the physical device itself.
The International Medical Device Regulators Forum went on to form the Software as a Medical Device Working Group when the need for a group-specific to software became apparent. The FDA chairs the SaMD Working Group, and they are responsible for regulating and approving software as a medical device.
Does the FDA Regulate SaMD?
Because software as a medical device refers to technology and equipment used in the medical field, they’re regulated by the FDA. Specifically, the branch of the FDA that’s responsible for software regulation is the Software as a Medical Device Working Group. SaMD is regulated based on several factors, the main one being how much of a risk it represents in the event of a malfunction. The more dangerous a medical device is the stricter regulations.
How Does the FDA Regulate SaMD?
The FDA regulates software as a medical device based mainly on its intended use in the medical field. For example, there will be stricter regulations for software responsible for keeping someone alive versus software used in smartphones to allow them to view MRI images.
SaMD has split into four separate risk management categories: Class I, Class II, Class III, and Class IV. Software that falls into the Class I risk category usually don’t undergo strict FDA regulation or any regulation. Devices in the Class II category may or may not require FDA regulation based on how they will be used. However, software as a medical device classified as Class III and Class IV will always need FDA regulation.
Because of how different most SaMD is, devices are often regulated on a case-by-case basis.
How to Get FDA Approval for Your SaMD
If you’re developing software as a medical device, the first thing you should find out is what risk category it will fall into. You should also know that international and global regulations may apply to your device if you use it outside of the United States. So, in addition to the FDA, you’ll also have to worry about the International Medical Device Regulators Forum. Here are some tips and tricks to ensure that your SaMD meets FDA regulations.
Use the FDA Pre-submission Option
One of the best things you can do as you’re developing SaMD is to perform a pre-submission to the FDA. Essentially, pre-submission is when you submit your software as a medical device early in the development process, knowing that it isn’t ready. Pre-submission puts you in the spotlight of the FDA, and they’ll give you feedback about your device and the areas that it’s lacking.
Develop Your Device Using a Risk-based Approach
One of the main things to keep in mind when developing your device is to use a risk-based approach. This means that you should be assessing the risk that the device represents and what duties it will be used to fulfill. The FDA will use this same approach, so using it to create your device will ensure it aligns with FDA regulations.
Be Aware of Your Specific FDA Regulations.
The FDA has information and guidelines readily available explaining exactly how they regulate various devices based on their risk factor. By adhering to these guidelines and following them based on your pre-submission, you can create technology to the specifications of the FDA.
For example, IEC 62304, a global standard released by the International Electrotechnical Commission, refers to the software life cycle processes. The standard outlines the life cycle specifications for creating medical software and software that is integrated into medical devices.
Make Sure to Use Accurate Data During Assessments.
Using correct and accurate data when you develop and submit your SaMD is absolutely essential. You can expect the FDA to crack down on your device and deal harshly with you if you submit incorrect or false data.
By adhering to the tips and tricks in this article and knowing what risk category your software as a medical device will fall into, you can easily meet FDA regulations. You should also note that the FDA is starting to use real-world evidence during the regulatory process. Keeping this in mind, you can develop necessary and applicable devices from day one.
If you are looking to create software as a medical device, contact DeviceLab today. We work directly in line with the FDA’s regulations to ensure you are on the right track for development. Contact us today to learn more.