An index is provided of relevant sections of Title 21 of the Code of Federal Regulations which cover the safety surveillance of medical devices which are required of manufactures in the United States. A relevant guideline prepared by the Food and Drug Administration is also indexed.
Title 21 Code of Federal Regulations. 803, 804, 812 and 821. Washington DC: U.S. Government Printing Office; 1996.
2.
Medical Devices: Medial Device Reporting; Annual Certification.Federal Register. March 20, 1997;62(54): 13302–13306.
3.
Medical Device Reporting for Manufacturers. Rockville, MD: Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health; March 1997.
4.
www.fda.gov/cdrh/manual/mdrman.html. Medical Device Reporting for Manufacturers. Rockville, MD: Department of Health and Human Services, Public Health Service, Food and Drug Administration; March 1997.
CurranCFEngleC.An index of United States federal regulations and guidelines which cover safety surveillance of drugs. Drug Inf J.1997;31(3):833–841.
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CurranCFSillsJMAn index of United States federal regulations and guidelines which cover clinical safety surveillance of biological products. Drug Inf J.1997;31(3):843–847.
