United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2002_register executive 2010-09-23 article Rules and Regulations D09002ee1c8198086 D09002ee1c8198127 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) 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. 67 FR 38878 https://www.govinfo.gov/app/details/FR-2002-06-06/02-14100 02-14100 fr06jn02-9 4160-01-S Docket No. 00N-1367 https://www.govinfo.gov/app/details/FR-2002-06-06/02-14100 https://www.govinfo.gov/content/pkg/FR-2002-06-06/html/02-14100.htm https://www.govinfo.gov/content/pkg/FR-2002-06-06/pdf/02-14100.pdf 15 p. 38878 38892 67 FR 38878 Title 21 Part 822 21 CFR Part 822 Postmarket Surveillance; Federal Register Vol. 67, Issue RULE 02-14100 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2002-07-08 Docket No. 00N-1367 4160-01-S 02-14100 Final rule.

The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) 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.

This rule is effective July 8, 2002. David L. Daly, Center for Devices and Radiological Health (HFZ-510), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3060. Medical devices: Postmarket surveillance, www.fda.gov www.fda.gov/cdrh/modact/critappr.pdf www.fda.gov/cdrh/resolvingdisputes www.fda.gov/cdrh/resolvingdisputes/ombudsman.html Vol. 67, no. 109 Office of the Federal Register, National Archives and Records Administration 2002-06-06 continuing daily deposited born digital 410 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2002-06-06 P0b002ee1809ab261 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06jn02 https://www.govinfo.gov/app/details/FR-2002-06-06 https://www.govinfo.gov/content/pkg/FR-2002-06-06/pdf/FR-2002-06-06.pdf https://www.govinfo.gov/content/pkg/FR-2002-06-06/xml/FR-2002-06-06.xml fdlp 38841 39240 DGPO 2010-09-23 2024-06-07 FR-2002-06-06 machine generated eng FR FR-2002-06-06 67 109