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 2024_register executive 2024-06-29 article Notices D09002ee1c863efc4 D09002ee1c863f04e 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products." This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices). The guidance describes FDA's recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance. FDA is providing recommendations for development and organization of device drug-delivery performance information to improve the consistency of this information in applications and submissions. The guidance is intended to facilitate and streamline development of drug delivery devices. 89 FR 54470 https://www.govinfo.gov/app/details/FR-2024-07-01/2024-14409 2024-14409 fr01jy24-69 4164-01-P Docket No. FDA-2024-D-2560 https://www.govinfo.gov/app/details/FR-2024-07-01/2024-14409 https://www.govinfo.gov/content/pkg/FR-2024-07-01/html/2024-14409.htm https://www.govinfo.gov/content/pkg/FR-2024-07-01/pdf/2024-14409.pdf 2 p. 54470 54471 89 FR 54470 Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability; Federal Register Vol. 89, Issue NOTICE 2024-14409 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2024-09-30 Docket No. FDA-2024-D-2560 4164-01-P 2024-14409 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products." This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices). The guidance describes FDA's recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance. FDA is providing recommendations for development and organization of device drug-delivery performance information to improve the consistency of this information in applications and submissions. The guidance is intended to facilitate and streamline development of drug delivery devices.

Submit either electronic or written comments on the draft guidance by September 30, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Patricia Love, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993, 301-796-8930, Patricia.Love@fda.hhs.gov or combination@fda.gov. Guidance: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, combination@fda.gov Patricia.Love@fda.hhs.gov https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 89, no. 126 Office of the Federal Register, National Archives and Records Administration 2024-07-01 continuing daily deposited born digital 399 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2024-07-01 P0b002ee1c863d37e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01jy24 https://www.govinfo.gov/app/details/FR-2024-07-01 https://www.govinfo.gov/content/pkg/FR-2024-07-01/pdf/FR-2024-07-01.pdf https://www.govinfo.gov/content/pkg/FR-2024-07-01/xml/FR-2024-07-01.xml fdlp 54329 54718 DGPO 2024-06-29 2024-06-29 FR-2024-07-01 machine generated eng FR FR-2024-07-01 89 126