FDA publishes amendment to UDI proposed rule
The FDA published an amendment to its unique device identifier (UDI) proposed rule (77 FR 40736), published July 10.
The FDA's Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the UDI proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting) or life-sustaining.
Comments on this amendment to the proposed rule are due by Dec. 19.
Read the amendment in full online.