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.
Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.