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 D09002ee1c81d3358 D09002ee1c81d33b8 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 In the Federal Register of July 25, 2001 (66 FR 38786), the Food and Drug Administration (FDA) amended its medical device classification regulations for class I devices to specifically add a reference to the general limitations on exemptions from premarket notification requirements from each generic device classified as exempt in each section. As published, an exemption from the premarket notification requirements and a reference to the general limitations language was inadvertently added to 12 device classifications that should not include the reference. These devices are not exempt from the requirements of premarket notification. This document corrects those errors. 66 FR 46951 https://www.govinfo.gov/app/details/FR-2001-09-10/01-22577 01-22577 fr10se01-5 4160-01-S Docket No. 01N-0073 https://www.govinfo.gov/app/details/FR-2001-09-10/01-22577 https://www.govinfo.gov/content/pkg/FR-2001-09-10/html/01-22577.htm https://www.govinfo.gov/content/pkg/FR-2001-09-10/pdf/01-22577.pdf 3 p. 46951 46953 66 FR 46951 Title 21 Part 872 21 CFR Part 872 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 892 21 CFR Part 892 Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices; Federal Register Vol. 66, Issue RULE 01-22577 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-09-10 Docket No. 01N-0073 4160-01-S 01-22577 Final rule; technical amendment.

In the Federal Register of July 25, 2001 (66 FR 38786), the Food and Drug Administration (FDA) amended its medical device classification regulations for class I devices to specifically add a reference to the general limitations on exemptions from premarket notification requirements from each generic device classified as exempt in each section. As published, an exemption from the premarket notification requirements and a reference to the general limitations language was inadvertently added to 12 device classifications that should not include the reference. These devices are not exempt from the requirements of premarket notification. This document corrects those errors.

This rule is effective September 10, 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. 175 Office of the Federal Register, National Archives and Records Administration 2001-09-10 continuing daily deposited born digital 137 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-09-10 P0b002ee180a0dd46 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10se01 https://www.govinfo.gov/app/details/FR-2001-09-10 https://www.govinfo.gov/content/pkg/FR-2001-09-10/pdf/FR-2001-09-10.pdf https://www.govinfo.gov/content/pkg/FR-2001-09-10/xml/FR-2001-09-10.xml fdlp 46937 47059 DGPO 2010-09-24 2024-06-08 FR-2001-09-10 machine generated eng FR FR-2001-09-10 66 175