federal_register: E7-12797

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-12797 General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the device, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses would remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device. 2007-07-03 2007 7 https://www.federalregister.gov/documents/2007/07/03/E7-12797/general-and-plastic-surgery-devices-reclassification-of-the-tissue-adhesive-for-topical https://www.govinfo.gov/content/pkg/FR-2007-07-03/pdf/E7-12797.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the device, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses would...

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