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 2022_register executive 2022-10-21 article Notices D09002ee1c7a144d5 D09002ee1c7a14977 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare." FDA has developed this draft guidance to propose select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or healthcare disparities. This draft guidance is not final nor is it for implementation at this time. 87 FR 64057 https://www.govinfo.gov/app/details/FR-2022-10-21/2022-22878 2022-22878 FR21OC22-79 4164-01-P Docket No. FDA-2022-D-1061 https://www.govinfo.gov/app/details/FR-2022-10-21/2022-22878 https://www.govinfo.gov/content/pkg/FR-2022-10-21/html/2022-22878.htm https://www.govinfo.gov/content/pkg/FR-2022-10-21/pdf/2022-22878.pdf 2 p. 64057 64058 87 FR 64057 Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 87, Issue NOTICE 2022-22878 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2022-12-20 Docket No. FDA-2022-D-1061 4164-01-P 2022-22878 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare." FDA has developed this draft guidance to propose select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or healthcare disparities. This draft guidance is not final nor is it for implementation at this time.

Submit either electronic or written comments on the draft guidance by December 20, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Ouided Rouabhi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G221, Silver Spring, MD 20993-0002, 240-402-2672; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. Guidance: Select Updates for the Breakthrough Devices Program; Reducing Disparities in Health and Healthcare, CDRH-Guidance@fda.hhs.gov https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 87, no. 203 Office of the Federal Register, National Archives and Records Administration 2022-10-21 continuing daily deposited born digital 226 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-10-21 P0b002ee1b7a2d45f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR21OC22 https://www.govinfo.gov/app/details/FR-2022-10-21 https://www.govinfo.gov/content/pkg/FR-2022-10-21/pdf/FR-2022-10-21.pdf https://www.govinfo.gov/content/pkg/FR-2022-10-21/xml/FR-2022-10-21.xml fdlp 63933 64148 DGPO 2022-10-21 2024-05-29 FR-2022-10-21 machine generated eng FR FR-2022-10-21 87 203