Access to Unapproved Devices Outlined in TGA Draft Guideline

Sept. 30, 2008 - Medical devices that are not approved in Australia may be used in patients with life-threatening illnesses provided the Therapeutic Goods Administration (TGA) is informed of the use within 28 days, according to a draft guideline. Australia’s Special Access Scheme considers the treating physician the approving authority for a device used with patients whose serious illnesses likely will result in death within months if early treatment is denied. The draft is the latest addition to TGA’s Australian Regulatory Guidelines for Medical Devices, which is intended to be a single reference source for all regulatory guidance documents.