United States Government Publishing Office
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Regulatory Information
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2020-12-30
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Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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D09002ee1bdb2d391
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 or Agency) is announcing the availability of a final guidance entitled ``Product Labeling for Laparoscopic Power Morcellators.'' This guidance updates recommended ``Contraindications'' and ``Warnings'' information to be included in product labeling to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients.
85 FR 86570
https://www.govinfo.gov/app/details/FR-2020-12-30/2020-28816
2020-28816
fr30de20-39
4164-01-P
Docket No. FDA-2014-D-1804
https://www.govinfo.gov/app/details/FR-2020-12-30/2020-28816
https://www.govinfo.gov/content/pkg/FR-2020-12-30/html/2020-28816.htm
https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28816.pdf
2 p.
86570
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85 FR 86570
Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-28816
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-1804
4164-01-P
2020-28816
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Product Labeling for Laparoscopic Power Morcellators.'' This guidance updates recommended ``Contraindications'' and ``Warnings'' information to be included in product labeling to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients.
The announcement of the guidance is published in the Federal Register on December 30, 2020.
Veronica Price, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2659, Silver Spring, MD 20993-0002, 301-796-6538.
Guidance:
Product Labeling for Laparoscopic Power Morcellators,
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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 250
Office of the Federal Register, National Archives and Records Administration
2020-12-30
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2020-12-30
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https://www.govinfo.gov/app/details/FR-2020-12-30
https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/FR-2020-12-30.pdf
https://www.govinfo.gov/content/pkg/FR-2020-12-30/xml/FR-2020-12-30.xml
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