federal_register: E8-30586

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

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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
E8-30586 Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." This guidance document describes a means by which male condoms made of natural rubber latex (latex condoms) may comply with the requirement of special controls for class II devices. FDA believes that the labeling recommendations contained in this guidance, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of latex condoms without spermicidal lubricant. In the Federal Register of November 10, 2008 (73 FR 66522), FDA published a final rule that amended the classification regulation for condoms from class II (performance standards) to class II (special controls) and designated this guidance document as the special control for male condoms made of natural rubber latex classified under that regulation. 2008-12-23 2008 12 https://www.federalregister.gov/documents/2008/12/23/E8-30586/guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls-guidance https://www.govinfo.gov/content/pkg/FR-2008-12-23/pdf/E8-30586.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 entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." This guidance document describes a...  

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