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 Part II Rules and Regulations D09002ee1c81d6598 D09002ee1c81d66bd 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 language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed. 66 FR 38786 https://www.govinfo.gov/app/details/FR-2001-07-25/01-17867 01-17867 fr25jy01-23 4160-01-S Docket No. 01N-0073 https://www.govinfo.gov/app/details/FR-2001-07-25/01-17867 https://www.govinfo.gov/content/pkg/FR-2001-07-25/html/01-17867.htm https://www.govinfo.gov/content/pkg/FR-2001-07-25/pdf/01-17867.pdf 34 p. 38786 38819 66 FR 38786 Title 21 Part 862 21 CFR Part 862 Title 21 Part 864 21 CFR Part 864 Title 21 Part 866 21 CFR Part 866 Title 21 Part 868 21 CFR Part 868 Title 21 Part 870 21 CFR Part 870 Title 21 Part 872 21 CFR Part 872 Title 21 Part 874 21 CFR Part 874 Title 21 Part 876 21 CFR Part 876 Title 21 Part 878 21 CFR Part 878 Title 21 Part 880 21 CFR Part 880 Title 21 Part 882 21 CFR Part 882 Title 21 Part 884 21 CFR Part 884 Title 21 Part 886 21 CFR Part 886 Title 21 Part 888 21 CFR Part 888 Title 21 Part 890 21 CFR Part 890 Title 21 Part 892 21 CFR Part 892 Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Technical Amendment; Federal Register Vol. 66, Issue RULE 01-17867 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-07-25 Docket No. 01N-0073 4160-01-S 01-17867 Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the language in its medical device classification regulations for class I devices for consistency, to include in sections where it was not present, a specific reference to the limitations on exemptions from premarket notification requirements for each generic device classified. The specific reference language was included when some class I generic devices were first exempted under provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). These amendments will provide the same reference for devices that were exempted before that time. The language is intended to conveniently provide the reference, and make the sections clear and easy to read. The status of the devices is not being changed.

This rule is effective July 25, 2001. Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190. Medical devices: Class I devices; premarket notification requirements, exemption; technical amendment, Vol. 66, no. 143 Office of the Federal Register, National Archives and Records Administration 2001-07-25 continuing daily deposited born digital 377 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-07-25 P0b002ee180a18891 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25jy01 https://www.govinfo.gov/app/details/FR-2001-07-25 https://www.govinfo.gov/content/pkg/FR-2001-07-25/pdf/FR-2001-07-25.pdf https://www.govinfo.gov/content/pkg/FR-2001-07-25/xml/FR-2001-07-25.xml fdlp 38523 38890 DGPO 2010-09-24 2024-06-08 FR-2001-07-25 machine generated eng FR FR-2001-07-25 66 143