Special Considerations for Software as a Medical Device

What are the Special Considerations for Software as a Medical Device (SaMD)?

Software not only needs Food and Drug Administration (FDA) review if it is used as a medical device, there are also a set of guidances and policies unique to software for consideration. While getting software innovations approved by the FDA can be daunting, it is not impossible. 

Your Product is Unique

MedTech Impact Partners develops and implements plans that uniquely meet your needs.

Understanding the FDA’s guidance and thinking on the recommended development and documentation sponsors should include in premarket submissions is essential for the most efficient review process.

FDA has worked over several  years to support creation of an international framework related to software. This, in addition to increased staffing of FDA software experts has improved the consistency and quality of software development, documentation, and review particularly with respect to activities such as risk assessment and management. Interpreting the guidance is the first step in preparing for a high quality submission.

Here’s how MedTech Impact Partners helps companies navigate the regulatory process along the way.

Evaluate The Landscape Unique to Your Product

• We conduct a structured research of premarket and post market activity.

• We learn more about your current team and benchmark against an ideal early stage digital health team.

• We then focus on special areas of concern. A typical focus area is Cybersecurity.

Develop a Plan

• We look at the relevant review times and compare to recent research to understand the time, cost and regulatory milestones for companies.

Execute the Plan

• We believe in early FDA contact focused on specific matters related to regulatory path, preclinical or clinical data requirements.

Our team is scheduling discovery meetings to learn more about your organization and goals. If you’re interested in learning more, please contact us, here.