1. Medtech Insight

FDA Issues UDI Final Rule, Removes Direct Marking Requirement For Implants

The long-awaited unique device identifier final rule is intended to help FDA, device companies and health care providers track medical devices. The rule addresses many of industry’s concerns with FDA’s initial proposal and was met with general support by companies.

In the much-anticipated FDA unique device identification final rule, the agency addressed many industry concerns with the proposed rule, particularly by eliminating direct part marking requirements for implantable devices and changing the date format for product labeling.

Companies praised the revisions, but also said they would be closely monitoring UDI implementation, which they say will be a...

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