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 D09002ee1c81c74ec D09002ee1c81c7576 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 amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements. 67 FR 5943 https://www.govinfo.gov/app/details/FR-2002-02-08/02-3076 02-3076 fr08fe02-8 4160-01-S Docket No. 00N-1034 https://www.govinfo.gov/app/details/FR-2002-02-08/02-3076 https://www.govinfo.gov/content/pkg/FR-2002-02-08/html/02-3076.htm https://www.govinfo.gov/content/pkg/FR-2002-02-08/pdf/02-3076.pdf 10 p. 5943 5952 67 FR 5943 Title 21 Part 821 21 CFR Part 821 Medical Devices; Device Tracking; Federal Register Vol. 67, Issue RULE 02-3076 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2002-05-09 Docket No. 00N-1034 4160-01-S 02-3076 Final rule.

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.

This rule is effective May 9, 2002. The information collection provisions of this final rule have been submitted to the Office of Management and Budget (OMB) for review. Prior to the effective date of this final rule, FDA will publish in the Federal Register a notice announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. Chester T. Reynolds, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4618. Medical devices: Device tracking, http://www.fda.gov/cdrh/fedregin.html Vol. 67, no. 27 Office of the Federal Register, National Archives and Records Administration 2002-02-08 continuing daily deposited born digital 473 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2002-02-08 P0b002ee1809b1bf8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08fe02 https://www.govinfo.gov/app/details/FR-2002-02-08 https://www.govinfo.gov/content/pkg/FR-2002-02-08/pdf/FR-2002-02-08.pdf https://www.govinfo.gov/content/pkg/FR-2002-02-08/xml/FR-2002-02-08.xml fdlp 5921 6157 DGPO 2010-09-23 2024-06-07 FR-2002-02-08 machine generated eng FR FR-2002-02-08 67 27