Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.
Milbank Q
; 102(2): 367-382, 2024 06.
Article
em En
| MEDLINE
| ID: mdl-38253988
ABSTRACT
Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Aprovação de Equipamentos
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article