This week the UDI (Unique Device Identification) proposed rule was released by the FDA. This represents a significant step forward for the FDA in managing medical devices throughout their lifecycle. Feedback from the community will come over the next 120 days.
We will be providing ongoing interpretation of the rule as we review it and organize our own comments and feedback for the FDA. The proposed rule can be found at www.regulations.gov.
A good summary of the rule can be reviewed at www.pmpnews.com.