FDA Grants More Time for Certain Unique Device Identifier (UDI) Requirements

FDA recently finalized a “guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time.”

Click to access the full story from RAPS Regulatory Focus, the Federal Register Notice (81 FR 59638), the new Guidance (Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices Guidance for Industry and Food and Drug Administration Staff) or here to begin a conversation with PDG about your UDI concerns or device development program.