TGA Offers Guidance on Electronic Instructions for Use
Australia’s Therapeutic Goods Administration (TGA) on Wednesday issued a new guideline detailing how manufacturers can comply with regulations for providing the instructions for use (IFU) for a medical device in electronic or online format.
In Australia, all medical devices must be provided with a label and IFU, as well as a patient implant card and patient information leaflet, if applicable.
TGA says the decision to allow manufacturers to provide electronic instructions for use (eIFU) is meant to reduce regulatory burdens on device makers and align the agency with other members of the International Medical Device Regulators Forum (IMDRF), such as the US Food and Drug Administration, who already allow for eIFUs in certain circumstances.
However, TGA says that only devices intended for professional use are eligible for eIFU only and devices supplied to the general public and in vitro diagnostics must include the IFU in paper form, though an eIFU may be provided as well.
Under Australian regulations, device makers can provide the IFU in a printed document or “other appropriate media” when it is not practicable to provide the IFU directly on the device or packaging.
According to TGA, the eIFU may be supplied in several ways, such as a help system or graphical user interface (GUI) by the device, stored on portable electronic media with the device, or via the manufacturer’s website.
When providing an eIFU, TGA says the document must state its release date and target regulatory jurisdiction, and that manufacturers should document the version history and continue to provide obsolete versions of the IFU for users that may need older versions.
Additionally, TGA says the eIFU must provide “all items specified in essential principle 13.4 of the Medical Device Regulations and comply with all other applicable Australian laws” and must be made available for at least 5 years, or the lifeline of the device, whichever is longer, from the date of the last manufactured device. For implantable devices, the eIFU must be made available for at least 15 years.
For eIFUs that are provided solely via a manufacturer’s website, TGA says the IFU must be easy to navigate to or search for and should be accessible without creating an account. The manufacturer must also specify whether the eIFU is approved for Australia and include a disclaimer if the eIFU is online before the device is available in the country.