TGA Offers New Guidance on Electronic Instructions for Use
Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices.
Current Australian regulations require all medical devices to include a label and instructions for use and, where applicable, a patient implant card and information leaflet. Only devices intended for professional use are eligible for electronic instructions for use (eIFU), according to the TGA, whereas devices supplied to the general public and in vitro diagnostics must include a paper copy of the IFU.
The eIFU may be supplied in several formats, including a graphical user interface (GUI) or a help system, and may be stored on portable electronic media or the manufacturer’s website. The eIFU provided to the TGA must state its release date and target regulatory jurisdiction as well as documenting version history. Manufacturers should continue providing obsolete versions of the IFU for the benefit of users with older versions of the device.
Manufacturers must make eIFUs available on their websites easy to navigate and search and not require users to create an account to access them, the agency said.