Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.
Intern Med J
; 43(1): 53-8, 2013 Jan.
Article
em En
| MEDLINE
| ID: mdl-22032398
ABSTRACT
While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Mamografia
/
Aprovação de Equipamentos
/
Publicidade
/
Detecção Precoce de Câncer
/
Legislação de Dispositivos Médicos
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
/
Screening_studies
Limite:
Female
/
Humans
País/Região como assunto:
Oceania
Idioma:
En
Revista:
Intern Med J
Assunto da revista:
MEDICINA INTERNA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Austrália