A UDI system could improve the quality of information in medical device adverse event reports, which would help the FDA identify product problems more quickly, better target recalls, and improve patient safety, according to the agency.
Under the proposed rule, a UDI would include the following:
- A device identifier, which is a unique numeric or alphanumeric code specific to a device model
- A production identifier, which includes the current production information for a device
The FDA said it will focus on the highest-risk medical devices first, exempting low-risk devices from some or all of the requirements as part of a risk-based, phased-in implementation approach. Comments on the proposed rule will be accepted for 120 days.
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