Essential SaMD Regulatory Documents: Curated List

If you are involved with Software as a Medical Device (SaMD), what regulatory guidance documents do you need to read, and in what order? With over 100 documents to choose from, it can be an overwhelming task. While you will still need regulatory experts, you can get started on building your background by using the table of documents we present at the end of this article. We recommend focusing on the highest-priority documents first, followed by the medium- and then low-priority documents. These documents will help you identify your SaMD’s software classification as well as understand and plan for what you need to submit to the FDA for clearance. Completing these crucial steps ahead of submission will save you time and set your software up for success. 

What is SaMD?

In short, it is standalone software that serves as a medical product in and of itself. While SaMD may take data input from external sensors, it is distinguished from software that is embedded in a medical device (known as SiMD, or Software in a Medical Device). For a more detailed exploration of SaMD, read our white paper “Software as a Medical Device (SaMD): What it is and Why it Matters?”

How is SaMD regulated?

With the exception of four guidance documents from the IMDRF, SaMD is neither specifically called out in FDA or EMA regulatory and guidance documents, nor in medical device standards. This makes it more challenging to explore the document landscape. Our table below will help guide your regulatory journey.

What is the best way to think about draft guidance vs final guidance?

In general, you always want to defer to the final guidance, unless the draft guidance is newer, clearer, safer and not inconsistent with the final guidance. Draft guidance can be extremely helpful when it is clarifying or closing gaps in the current guidance. It can also prepare you for major upcoming changes.