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 1996_register executive 2010-09-24 article Rules and Regulations D09002ee1be0289bf D09002ee1be028a5c United States Department of Health and Human Services originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is reclassifying scented or scented deodorized menstrual pads from class II into class I based on new information respecting such device. FDA is also exempting this device, and one already classified generic type of class I device, unscented menstrual pads, from the requirement of premarket notification, with limitations. FDA has determined that manufacturers' submissions of premarket notifications for these devices are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. These exemptions allow the agency to make better use of its resources and thus better serve the public. 61 FR 67713 https://www.govinfo.gov/app/details/FR-1996-12-24/96-32550 96-32550 fr24de96-13 4160-01-F Docket No. 95N-0139 https://www.govinfo.gov/app/details/FR-1996-12-24/96-32550 https://www.govinfo.gov/content/pkg/FR-1996-12-24/html/96-32550.htm https://www.govinfo.gov/content/pkg/FR-1996-12-24/pdf/96-32550.pdf 3 p. 67713 67715 61 FR 67713 Title 21 Part 884 21 CFR Part 884 Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices; Federal Register Vol. 61, Issue RULE 96-32550 DEPARTMENT OF HEALTH AND HUMAN SERVICES 1997-02-24 Docket No. 95N-0139 4160-01-F 96-32550 Final rule.

The Food and Drug Administration (FDA) is reclassifying scented or scented deodorized menstrual pads from class II into class I based on new information respecting such device. FDA is also exempting this device, and one already classified generic type of class I device, unscented menstrual pads, from the requirement of premarket notification, with limitations. FDA has determined that manufacturers' submissions of premarket notifications for these devices are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. These exemptions allow the agency to make better use of its resources and thus better serve the public.

Effective February 24, 1997. Beginning on February 24, 1997, all device manufacturers who have 510(k) submissions pending FDA review for devices falling within a generic category that is subject to this rule, will receive a letter stating that the device is exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act. Melpomeni K. Jeffries, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 2186. Vol. 61, no. 248 Office of the Federal Register, National Archives and Records Administration 1996-12-24 continuing daily deposited born digital 251 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1996-12-24 P0b002ee180a2ddca 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24de96 https://www.govinfo.gov/app/details/FR-1996-12-24 https://www.govinfo.gov/content/pkg/FR-1996-12-24/pdf/FR-1996-12-24.pdf fdlp 67687 67926 DGPO 2010-09-24 2023-05-06 FR-1996-12-24 machine generated eng FR FR-1996-12-24 61 248