DJO Global - Dr Comfort footware

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by DJO Global Pty Ltd

I, David Poulton, Delegate of the Secretary to the Department of Health, on receipt of an application from DJO Global Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) (i) - (iii) below for use in advertisements directed to consumers, for the product identified in paragraph (b):

1.  
   1. Representations which refer to 'diabetes' to the effect: 'Dr Comfort footwear is suitable for people living with diabetes';
   2. Representations which refer to 'diabetes' to the effect: 'Dr Comfort footwear may assist in the prevention of foot complications which can be associated with diabetes'; and
   3. Representation which refer to 'diabetes' and 'diabetic foot complications/disease; in the context of providing accurate, balanced and contemporary statistical information consistent with the body of scientific knowledge about the prevalence of diabetic foot disease in Australia *
   4. *required balance to be achieved:
      1. by not stating or in any way implying the use of the Devices is the only, or the predominant, way to manage or reduce risk of diabetic foot disease.
      2. The statistics are presented in association with the need for an individual diabetes management plan, developed and managed by a medical practitioner.
2. Orthosis, footwear, orthopaedic, shoe (ARTG 204014)

Dated this 20th day of March 2019

Signed electronically

David Poulton
Delegate of the Secretary to the Department of Health Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch