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 2015-09-19 article Notices D09002ee1c7f71bea D09002ee1c7f71c7c 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 or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner) or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee may consider topics such as Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device- related quality of life or health status issues, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics. 80 FR 57007 https://www.govinfo.gov/app/details/FR-2015-09-21/2015-23521 2015-23521 fr21se15-85 4164-01-P Docket No. FDA-2015-N-3166 https://www.govinfo.gov/app/details/FR-2015-09-21/2015-23521 https://www.govinfo.gov/content/pkg/FR-2015-09-21/html/2015-23521.htm https://www.govinfo.gov/content/pkg/FR-2015-09-21/pdf/2015-23521.pdf 2 p. 57007 57008 80 FR 57007 Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments; Federal Register Vol. 80, Issue NOTICE 2015-23521 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-11-20 Docket No. FDA-2015-N-3166 4164-01-P 2015-23521 Notice; establishment of public docket; request for comments.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner) or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee may consider topics such as Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device- related quality of life or health status issues, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics.

Comments received by November 20, 2015, will be provided to the Agency. Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510. Establishment of the Patient Engagement Advisory Committee , http://www.regulations.gov Vol. 80, no. 182 Office of the Federal Register, National Archives and Records Administration 2015-09-21 continuing daily deposited born digital 185 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-09-21 P0b002ee18d8fc56b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se15 https://www.govinfo.gov/app/details/FR-2015-09-21 https://www.govinfo.gov/content/pkg/FR-2015-09-21/pdf/FR-2015-09-21.pdf https://www.govinfo.gov/content/pkg/FR-2015-09-21/xml/FR-2015-09-21.xml fdlp 56893 57068 DGPO 2015-09-19 2024-06-02 FR-2015-09-21 machine generated eng FR FR-2015-09-21 80 182