SomnoMed mandibular advancement splint (MAS)

Published in the Commonwealth of Australia Gazette No. GN 12, 29 March 2006

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS REGULATIONS

I, RITA MACLACHLAN, Director, Office of Devices, Blood and Tissues, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of section 42DF of the Therapeutic Goods Act 1989, give notice that the restricted representation described in paragraph (a) below, has been approved for use in advertisements directed to consumers, for the category of products listed in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that use of the goods described in paragraph (b) below:
   "may be a suitable treatment for Obstructive Sleep Apnoea for some patients"
2. SomnoMed Mandibular Advancement Splint (MAS)
3. The claims made in advertisements for this device must be consistent with the manufacturer's intended purpose and the current clinical evidence.
   The advertisements for this device must comply with the general provisions about advertising therapeutic goods in Chapter 5, Division 3 of the Therapeutic Goods Act 1989
   The advertisements in which the representations appear made must emphasize that this form of treatment is not generally accepted as the first line treatment for sleep apnoea and include information on the necessity for diagnosis and monitoring by a suitably qualified healthcare professional.

Dated this 20th day of March 2006

RITA MACLACHLAN
Delegate of the Secretary to the Department of Health and Ageing