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2019-05-08
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Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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D09002ee1bdb77330
United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).'' This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.
84 FR 20143
https://www.govinfo.gov/app/details/FR-2019-05-08/2019-09380
2019-09380
fr08my19-61
4164-01-P
Docket No. FDA-2014-D-2245
https://www.govinfo.gov/app/details/FR-2019-05-08/2019-09380
https://www.govinfo.gov/content/pkg/FR-2019-05-08/html/2019-09380.htm
https://www.govinfo.gov/content/pkg/FR-2019-05-08/pdf/2019-09380.pdf
3 p.
20143
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84 FR 20143
Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-09380
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-2245
4164-01-P
2019-09380
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).'' This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.
The announcement of the guidance is published in the Federal Register on May 8, 2019.
Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927.
Guidance:
Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57)
,
CDRH-Guidance@fda.hhs.gov
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 89
Office of the Federal Register, National Archives and Records Administration
2019-05-08
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243 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2019-05-08
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https://www.govinfo.gov/app/details/FR-2019-05-08
https://www.govinfo.gov/content/pkg/FR-2019-05-08/pdf/FR-2019-05-08.pdf
https://www.govinfo.gov/content/pkg/FR-2019-05-08/xml/FR-2019-05-08.xml
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