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2011-06-22
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Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability
Notices
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D09002ee1bdd05aff
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.
76 FR 36543
https://www.govinfo.gov/app/details/FR-2011-06-22/2011-15570
2011-15570
fr22jn11-83
4160-01-P
Docket No. FDA-2011-D-0469
https://www.govinfo.gov/app/details/FR-2011-06-22/2011-15570
https://www.govinfo.gov/content/pkg/FR-2011-06-22/html/2011-15570.htm
https://www.govinfo.gov/content/pkg/FR-2011-06-22/pdf/2011-15570.pdf
2 p.
36543
36544
76 FR 36543
Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-15570
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0469
4160-01-P
2011-15570
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.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at any time (see Sec. 10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by September 19, 2011.
Molly Story, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2533, Silver Spring, MD 20993-0002, 301-796-1456, e-mail: molly.story@fda.hhs.gov.
Draft Guidance for Industry; Availability:
Applying Human Factors and Usability Engineering to Optimize Medical Device Design
,
dsmica@fda.hhs.gov
molly.story@fda.hhs.gov
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 120
Office of the Federal Register, National Archives and Records Administration
2011-06-22
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584 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2011-06-22
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2011-06-22
https://www.govinfo.gov/content/pkg/FR-2011-06-22/pdf/FR-2011-06-22.pdf
https://www.govinfo.gov/content/pkg/FR-2011-06-22/xml/FR-2011-06-22.xml
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