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 2016-02-03 article Notices D09002ee1c7f69aac D09002ee1c7f69b3b 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "List of Highest Priority Devices for Human Factors Review." FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. This draft guidance is not final nor is it in effect at this time. 81 FR 5756 https://www.govinfo.gov/app/details/FR-2016-02-03/2016-01889 2016-01889 fr03fe16-70 4164-01-P Docket No. FDA-2015-D-4599 https://www.govinfo.gov/app/details/FR-2016-02-03/2016-01889 https://www.govinfo.gov/content/pkg/FR-2016-02-03/html/2016-01889.htm https://www.govinfo.gov/content/pkg/FR-2016-02-03/pdf/2016-01889.pdf 3 p. 5756 5758 81 FR 5756 List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 81, Issue NOTICE 2016-01889 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-4599 4164-01-P 2016-01889 Notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "List of Highest Priority Devices for Human Factors Review." FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. FDA believes these device types have clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices. 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 May 3, 2016. Shannon Hoste, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2531, Silver Spring, MD 20993-0002, 240-402-3747, or shannon.hoste@fda.hhs.gov. Guidance: List of Highest Priority Devices for Human Factors Review , CDRH-Guidance@fda.hhs.gov shannon.hoste@fda.hhs.gov http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 22 Office of the Federal Register, National Archives and Records Administration 2016-02-03 continuing daily deposited born digital 316 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-02-03 P0b002ee18e6cf7e6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03fe16 https://www.govinfo.gov/app/details/FR-2016-02-03 https://www.govinfo.gov/content/pkg/FR-2016-02-03/pdf/FR-2016-02-03.pdf https://www.govinfo.gov/content/pkg/FR-2016-02-03/xml/FR-2016-02-03.xml fdlp 5573 5880 DGPO 2016-02-03 2024-06-02 FR-2016-02-03 machine generated eng FR FR-2016-02-03 81 22