FDA Medical Device Regulation

Fda Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

Volumn , Issue , 2008, Pages 125-165

  Sall, Barry ^a  

^a PAREXEL INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85000625687     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9781420073553-8     Document Type: Chapter

References (9)

1. Food and Drug Administration, Intercenter Agreements, October 1991. Available at: http://www .fda.gov/oc/combination/intercenter.html.
2. Food and Drug Administration, 510(k) database. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
3. Food and Drug Administration, available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
4. Food and Drug Administration, available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.
5. Food and Drug Administration. Final Rule. Medical Devices; Current Good Manufacturing Practice (CGMP). Final Rule; Quality System Regulation. Federal Register 1996; 61:195,52602-52662.
6. Food and Drug Administration, available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
7. Food and Drug Administration, available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
8. Helmus MN, ed. Biomaterials in the Design and Reliability of Medical Devices. New York: Kluwer Academic/Plenum Publishers, 2003.
9. Trautman K. The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices. Milwaukee, WI: ASQC Quality Press, 1997.