1ST FDA Compliance Deadline for Class III Devices
- September 24, 2014 is the first compliance deadline for labels and packages of Class III devices
- Class III Stand-alone Software and devices licensed under the PHS Act to be “compliant.”
- Devices must have a UDI on its packages and labels
- Human readable dates must be formatted as YYYY-MM-DD (§801.18)
- Information submitted to the Global UDI Database (GUDID) (§830.300) by this date
Resources from
Medical Device Academy
- Free Webinar: FDA UDI Regulation’s Impact on Medical Device Labelers
- UDI Blogs – Click Here
