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

摘要

FDA believes that special controls, when combined with general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the automated blood cell separator device operating on a centrifugal or filtration separation principle and intended for the routine collection of blood and blood components. A manufacturer that intends to market a device of this generic type should (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in Title 21 Code of Federal Regulations (CFR), Part 807, Subpart E, (2) address the specific risks to health associated with the automated blood cell separator device identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device (see also 21 CFR 807.85). This guidance document identifies the relevant classification regulation, which provides a description of the applicable automated blood cell separator device (refer to section IV. Device Description, below). In addition, other sections of this special controls guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with general controls, will ordinarily address the risks associated with these automated blood cell separator devices.