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 2001_register executive 2010-09-24 article Rules and Regulations D09002ee1c81de286 D09002ee1c81de314 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 reclassifying six cardiovascular preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations. 66 FR 18540 https://www.govinfo.gov/app/details/FR-2001-04-10/01-8829 01-8829 fr10ap01-15 4160-01-S Docket No. 99N-0035 https://www.govinfo.gov/app/details/FR-2001-04-10/01-8829 https://www.govinfo.gov/content/pkg/FR-2001-04-10/html/01-8829.htm https://www.govinfo.gov/content/pkg/FR-2001-04-10/pdf/01-8829.pdf 3 p. 18540 18542 66 FR 18540 Title 21 Part 870 21 CFR Part 870 Title 21 Part 886 21 CFR Part 886 Medical Devices; Reclassification of Six Cardiovascular Preamendments Class III Devices into Class II; Federal Register Vol. 66, Issue RULE 01-8829 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-05-10 Docket No. 99N-0035 4160-01-S 01-8829 Final rule.

The Food and Drug Administration (FDA) is reclassifying six cardiovascular preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations.

This rule is effective May 10, 2001. Bette L. Lemperle, Center for Devices and Radiological Health (HFZ-453), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262. Medical devices: Cardiovascular devices Reclassification of six preamendments Class III devices into Class II, http://www.fda.gov/cdrh http://www.fda.gov/cdrh/ODE Vol. 66, no. 69 Office of the Federal Register, National Archives and Records Administration 2001-04-10 continuing daily deposited born digital 205 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-04-10 P0b002ee180a0d2a9 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10ap01 https://www.govinfo.gov/app/details/FR-2001-04-10 https://www.govinfo.gov/content/pkg/FR-2001-04-10/pdf/FR-2001-04-10.pdf https://www.govinfo.gov/content/pkg/FR-2001-04-10/xml/FR-2001-04-10.xml fdlp 18521 18715 DGPO 2010-09-24 2024-06-08 FR-2001-04-10 machine generated eng FR FR-2001-04-10 66 69