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federal_register: 00-12526

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present.

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

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
00-12526 Obstetrical and Gynecological Devices; Classification of Female Condoms Rule The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997. 2000-05-18 2000 5 https://www.federalregister.gov/documents/2000/05/18/00-12526/obstetrical-and-gynecological-devices-classification-of-female-condoms https://www.govinfo.gov/content/pkg/FR-2000-05-18/pdf/00-12526.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This...

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