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

Apr 16, 2019 | Medical Devices, Unique Device Identification

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.

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.