Hematology and Pathology Devices; Reclassification of the Automated Differential Cell Counter
Information
Type
Rule
Regulated products
Medical Devices
Published
January 14, 2002
Last updated
January 14, 2002
Description
Document number 02-792. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)