federal_register: 05-4758
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 05-4758 | Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle | Proposed Rule | The Food and Drug Administration (FDA) is proposing to reclassify from class III to class II (special controls) the automated blood cell separator device operating on a centrifugal separation principle and intended for the routine collection of blood and blood components. This proposed rule would also modify the special control for the device with the same intended use but operating on a filtration separation principle. The reclassification is being proposed on FDA's own initiative under procedures set forth in FDA regulations and based on information provided to FDA. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency proposes this reclassification because special controls, in addition to general controls, are capable of providing reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document entitled "Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle," which will serve as the special control if this proposal becomes final. | 2005-03-10 | 2005 | 3 | https://www.federalregister.gov/documents/2005/03/10/05-4758/medical-devices-hematology-and-pathology-devices-reclassification-from-class-iii-to-class-ii-of | https://www.govinfo.gov/content/pkg/FR-2005-03-10/pdf/05-4758.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to reclassify from class III to class II (special controls) the automated blood cell separator device operating on a centrifugal separation principle and intended for the routine collection of blood... |