Putting It in Writing

Abstract

In the medical device industry, the practice of creating a "Letter to File," "Note to File," or "Memo to File" is employed to document modifications to a device in the USA for regulatory and compliance purposes. Although the U.S. Food and Drug Administration (FDA) have provided guidance on this topic over the years, there has not been a thorough exploration of this concept. Medical device manufacturers frequently make changes to their FDA-cleared products, but determining whether to handle the change internally using a Letter to File or notify the FDA can be unclear. This article provides a comprehensive overview of what a Letter to File is, the purpose of writing one, and the appropriate situations in which a company might use it. Additionally, it also discusses the contents of a typical Letter to File, including the necessary elements and the best practices for writing it effectively and consequences of making the wrong decision. By providing guidance on the Letter to File process, this article aims to assist professionals in the medical device industry in maintaining precise records that can support their organizations in any regulatory situation.