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 2016_register executive 2016-07-16 article Notices D09002ee1c7f58b2f D09002ee1c7f58bb4 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 announcing the following public workshop entitled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization. 81 FR 46694 https://www.govinfo.gov/app/details/FR-2016-07-18/2016-16887 2016-16887 fr18jy16-68 4164-01-P Docket No. FDA-2016-N-0001 https://www.govinfo.gov/app/details/FR-2016-07-18/2016-16887 https://www.govinfo.gov/content/pkg/FR-2016-07-18/html/2016-16887.htm https://www.govinfo.gov/content/pkg/FR-2016-07-18/pdf/2016-16887.pdf 2 p. 46694 46695 81 FR 46694 Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop; Federal Register Vol. 81, Issue NOTICE 2016-16887 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-N-0001 4164-01-P 2016-16887 Notice of public workshop.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers." The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.

The public workshop will be held on October 27, 2016, from 8:30 a.m. to 5 p.m. and October 28, 2016, from 8:30 a.m. to 4 p.m. Felicia Brayboy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3464, Silver Spring, MD 20993, 301-796- 8086, Felicia.Brayboy@fda.hhs.gov. Meetings: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Workshop , Felicia.Brayboy@fda.hhs.gov Peggy.roney@fda.hhs.gov http://www.adobe.com/go/connectpro_overview http://www.fda.gov http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm http://www.regulations.gov https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Vol. 81, no. 137 Office of the Federal Register, National Archives and Records Administration 2016-07-18 continuing daily deposited born digital 270 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-07-18 P0b002ee1904aaff3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18jy16 https://www.govinfo.gov/app/details/FR-2016-07-18 https://www.govinfo.gov/content/pkg/FR-2016-07-18/pdf/FR-2016-07-18.pdf https://www.govinfo.gov/content/pkg/FR-2016-07-18/xml/FR-2016-07-18.xml fdlp 46567 46826 DGPO 2016-07-16 2024-06-01 FR-2016-07-18 machine generated eng FR FR-2016-07-18 81 137