Panel Lauds UDI, But Worries About Enforcement, Other Details

The FDA last week got a preview of the comments it can expect in response to its unique device identifier (UDI) draft rule ranging from whether a change in UDI would require a new supplemental PMA or 510(k) to questions about date formatting required by the rule. Dan O’Leary, president of Ombu Enterprises, noted that the rule raises a number of challenges — especially for companies with fewer than 50 employees that may lack the resources to implement it.
Devices & Diagnostics Letter