Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.
Fed Regist
; 67(9): 1606-7, 2002 Jan 14.
Article
em En
| MEDLINE
| ID: mdl-11800006
ABSTRACT
The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.
Buscar no Google
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Patologia
/
United States Food and Drug Administration
/
Contagem de Células Sanguíneas
/
Hematologia
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2002
Tipo de documento:
Article