Putting It in Writing
Purpose and Best Practices of Letter-to-File for Medical Devices
Keywords:Medical device, Medical device company, Letter to file, Impact, Change Management, Modification, FDA, LTF, Changes, compliance, regulatory
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.
- 2023-05-30 (3)
- 2023-05-30 (2)
- 2023-04-17 (1)
Copyright (c) 2023 Somya Gupta, Farha Ahmed, Ramya Krishnadas
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
By submitting content to the Journal of Regulatory Science (JRS), authors agree to the following terms:
- Authors retain copyright and grant the JRS the right of first publication. Authors retain patent, trademark, and other intellectual property rights (including research data) and grant third parties the right to use, reproduce, and share the article according to the Creative Commons — Attribution-NonCommercial 4.0 International — CC BY-NC 4.0 license agreement. The JRS is an open access journal and, as a result, articles are free to use with proper acknowledgment of the work's authorship and initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process.
- If excerpts from other copyrighted works are included, the author(s) must obtain written permission from the copyright owners and credit the source(s) in the article.
- The publication of the submission has been approved by all co-authors and responsible authorities at the institute or organization where the work has been carried out.
- Copyright has not been breached in seeking publication of the submission.