federal_register: 2020-03827

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2020-03827 Product Labeling for Laparoscopic Power Morcellators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Product Labeling for Laparoscopic Power Morcellators." This draft guidance proposes updated "Contraindications" and "Warnings" in product labeling information to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). This draft guidance is not final nor is it in effect at this time. 2020-02-26 2020 2 https://www.federalregister.gov/documents/2020/02/26/2020-03827/product-labeling-for-laparoscopic-power-morcellators-draft-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2020-02-26/pdf/2020-03827.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Product Labeling for Laparoscopic Power Morcellators." This draft guidance proposes updated "Contraindications" and "Warnings" in product...  

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