US FDA best practices for initiating early feasibility studies for neurological devices in the United States.
J Neurosurg
; 136(1): 282-286, 2022 Jan 01.
Article
em En
| MEDLINE
| ID: mdl-34087794
ABSTRACT
This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Estudos de Viabilidade
/
Equipamentos e Provisões
/
Doenças do Sistema Nervoso
Tipo de estudo:
Guideline
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article