0910-AC31 200204 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Postmarket Surveillance The Food and Drug Administration (FDA) is implementing a final rule for the postmarket surveillance provisions of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health. Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage No No 21 CFR 822 21 USC 331 21 USC 352 21 USC 360i 21 USC 360l 21 USC 371 21 USC 374 ... No NPRM 08/29/2000 65 FR 52376 NPRM Comment Period End 11/27/2000 Final Action 06/00/2002 Yes Businesses None No NA Not Collected Joseph Sheehan M. 0910 Food and Drug Administration FDA 301 827-2974 301 594-4765 joseph.sheehan@fda.hhs.gov HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville MD 20850