federal_register: 2020-28816

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2020-28816 Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability Notice 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. 2020-12-30 2020 12 https://www.federalregister.gov/documents/2020/12/30/2020-28816/product-labeling-for-laparoscopic-power-morcellators-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28816.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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