This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Reference Checklist: FDA Medical Device UDI Regulation Records, Reports, SOPs


The FDA Unique Device Identification (UDI) regulation requires manufacturers to identify their medical devices with a UDI placed on their product and package labels. Of equal importance, the FDA UDI regulation also requires manufactures to report medical device information to the FDA Global UDI Database (GUDID) in a compliant manner and include UDI in various records, reports, and standard operating procedures (SOPs).

For your convenience, Reed Tech has compiled a comprehensive reference document.

FDA Med Device UDI

The FDA Medical Device UDI Regulation Records, Reports, & SOPs 

Table of Contents
  • Checklist for UDI Records, Reporting and SOPs
  • UDI Records/Reports/SOPs – Regulation List
  • UDI Records/Reports/SOPs – Regulation details w/CFR Excerpts
  • Reference Links

The UDI-related requirements contained in this document are recommended for inclusion in a medical device manufacturer’s policy, procedure, and instruction documentation and implemented to conform to the UDI regulations and guidance documents.

Note that numerical references are to the electronic Code of Federal Regulations; MDR = Medical Device Reporting; QSR = Quality System Requirements.

Fill in this brief form to download the FDA Medical Device UDI Reference document. We hope you find it of value. 

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.