Understanding the Regulation of Off-Label Use of Medical Devices in Australia

1. Purpose of the Guidance

This guidance explains the concept of off-label use of medical devices in Australia, clarifies the associated regulatory framework, and outlines responsibilities and limitations for clinicians, sponsors (suppliers/manufacturers), and advertisers. It highlights that while off-label use may occur in clinical practice, promotion of such use is heavily restricted. TGA Guidance: Understanding regulation of off-label use of medical devices

2. Definition of Off-Label Use

Off-label use means using a medical device for a purpose or indication not listed as one of the approved indications for use in the Australian Register of Therapeutic Goods (ARTG). The ARTG entry specifies the device's intended uses based on the sponsor's certification during inclusion. Use outside these approved indications constitutes off-label use. TGA Guidance: Understanding regulation of off-label use of medical devices

The Therapeutic Goods Act 1989 (the Act) does not regulate clinical practice. Off-label use is a clinical decision made at the discretion of the treating clinician, who bears responsibility for:

• Obtaining informed consent from the patient (including disclosure that the use is off-label)
• Ensuring the device is the most appropriate treatment option for the patient. TGA Guidance: Understanding regulation of off-label use of medical devices

3. Special Access Scheme Category B (SAS B) and Supply

Sponsors do not require SAS B approval, and the TGA has no authority to grant such approval, for supplying an ARTG-included medical device — even for off-label use. This differs from medicines and biologicals, where different legislative requirements may apply for off-label supply or use. TGA Guidance: Understanding regulation of off-label use of medical devices

4. Advertising and Promotion of Off-Label Use

Sponsors must ensure all advertising material aligns with the device's intended purpose as certified in the ARTG application (subsection 41FN(5) of the Act). Advertising a device for an unapproved purpose is prohibited.

Key restrictions include:

• Criminal and civil penalty provisions apply for advertising a medical device for a purpose not approved in the ARTG (sections 41ML and 41MLB of the Act).
• The Act's definition of 'advertise' encompasses any statement, pictorial representation, or design.
• These rules apply even to advertising directed solely at health professionals.
• Sponsors may provide non-promotional information (e.g., Product Information on off-label usage) only upon specific request from a treating clinician.
• Unsolicited information about off-label uses is likely considered promotion and treated as an advertisement, risking penalties. TGA Guidance: Understanding regulation of off-label use of medical devices

Sponsors should be mindful of the condition of inclusion under subsection 41FN(5) and the associated offence/penalty provisions.

5. Practical Distinctions: Label Use vs. Prohibited Promotion

• Label use (on-label) refers to use consistent with the intended purpose in the ARTG entry.
• Promoted claims must match this intended purpose; any promotion of unapproved (off-label) uses is prohibited.
• Non-promotional, reactive provision of information is permitted only when requested; proactive or unsolicited dissemination is viewed as advertising.

6. Enforcement and Compliance Considerations

The TGA enforces these rules primarily through the penalty provisions in sections 41ML and 41MLB. Sponsors risk criminal or civil penalties for non-compliant advertising. Clinicians retain autonomy in clinical decisions, but sponsors have no role in promoting off-label applications.

7. Additional Notes

This guidance relates directly to the Therapeutic Goods Act 1989, particularly subsections 41FN(5), 41ML, and 41MLB. It does not cover detailed labelling requirements, instructions for use (IFU), or evidence standards for approved claims, focusing instead on off-label promotion restrictions. The page has undergone updates, including a title change from 'Off-label use of medical devices' to the current version, with improvements in structure and features. TGA Guidance: Understanding regulation of off-label use of medical devices