federal_register: 2014-27857

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-27857 Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled "Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators." FDA is issuing this guidance to recommend the addition of specific safety statements to the product labeling for laparoscopic power morcellators (LPMs). The Agency is making these recommendations in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids. FDA believes this effort will promote the safe and effective use of LPMs when used for gynecologic surgeries. 2014-11-25 2014 11 https://www.federalregister.gov/documents/2014/11/25/2014-27857/immediately-in-effect-guidance-document-product-labeling-for-laparoscopic-power-morcellators https://www.govinfo.gov/content/pkg/FR-2014-11-25/pdf/2014-27857.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry and FDA staff entitled "Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators." FDA is issuing this guidance to...  

Links from other tables