Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

This information collection supports Food and Drug Administration (FDA, us or we) regulations. Under the Safe Medical Devices Act of 1990 (Public Law 101 – 629), FDA may establish special controls, including performance standards, postmarket surveillance, patient registries, guidelines, and other appropriate actions it believes necessary to provide reasonable assurance of the safety and effectiveness of a device. The special controls guidance document entitled, “Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle,” serves as the special control for the automated blood cell separator device operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components, as codified under 21 CFR 864.9245.

The latest form for Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle expires 2021-08-31 and can be found here.