Healthcare Software

Software Documentation to include in an FDA Premarket Submission

Although it is not necessary to submit every piece of documentation as part of an FDA premarket submission, it is still important to have the document on hand should something change along the way. It also goes a long way to demonstrate a good development process.

In the table below, I list the documents along with columns for whether the document is required or if it is FDA application specific, meaning that it wouldn't be part of a normal development process. For example, normally I wouldn't make a document called "Level of Concern," but for the FDA it is required for all submissions. Those interested can read more about the different document types on the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices page.

So what we can see here is that if you follow a good software process and develop the documentation you need, there is not too much more you have to do for premarket approval. Keep in mind too that all the documents listed above are potentially required. Producing all of them during development mitigates the risk that the FDA ask for it at later date.