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 2015_register executive 2015-04-01 article Notices D09002ee1c7f7c2b2 D09002ee1c7f7c344 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States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Procedures for Meetings of the Medical Devices Advisory Committee." The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings. This guidance supplements existing FDA Agency-wide guidance on the conduct of Advisory Committee meetings. This draft guidance is not final nor is it in effect at this time. 80 FR 17439 https://www.govinfo.gov/app/details/FR-2015-04-01/2015-07438 2015-07438 fr01ap15-59 4164-01-P Docket No. FDA-2015-D-0838 https://www.govinfo.gov/app/details/FR-2015-04-01/2015-07438 https://www.govinfo.gov/content/pkg/FR-2015-04-01/html/2015-07438.htm https://www.govinfo.gov/content/pkg/FR-2015-04-01/pdf/2015-07438.pdf 2 p. 17439 17440 80 FR 17439 Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 80, Issue NOTICE 2015-07438 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-0838 4164-01-P 2015-07438 Notice.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Procedures for Meetings of the Medical Devices Advisory Committee." The Center for Devices and Radiological Health (CDRH) is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory Committee panels other than the Dispute Resolution Panel (DRP). This guidance describes the general circumstances in which CDRH consults with a panel, the process for exchange of information between CDRH, the members of the panel, industry, and the public, and the conduct of panel meetings. This guidance supplements existing FDA Agency-wide guidance on the conduct of Advisory Committee meetings. This draft guidance is not final nor is it in effect at this time.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 1, 2015. James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002, 301-796-6313. Guidance: Procedures for Meetings of the Medical Devices Advisory Committee , CDRH-Guidance@fda.hhs.gov http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073726.pdf http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm http://www.regulations.gov Vol. 80, no. 62 Office of the Federal Register, National Archives and Records Administration 2015-04-01 continuing daily deposited born digital 386 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-04-01 P0b002ee18bf6bb61 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01ap15 https://www.govinfo.gov/app/details/FR-2015-04-01 https://www.govinfo.gov/content/pkg/FR-2015-04-01/pdf/FR-2015-04-01.pdf https://www.govinfo.gov/content/pkg/FR-2015-04-01/xml/FR-2015-04-01.xml fdlp 17307 17682 DGPO 2015-04-01 2024-06-02 FR-2015-04-01 machine generated eng FR FR-2015-04-01 80 62