federal_register: E8-30440

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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
E8-30440 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Tissue Expander." This draft guidance document describes a means by which the tissue expander device type may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify this device type into class II (special controls). This draft guidance is not final nor is it in effect at this time. 2008-12-22 2008 12 https://www.federalregister.gov/documents/2008/12/22/E8-30440/draft-guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls https://www.govinfo.gov/content/pkg/FR-2008-12-22/pdf/E8-30440.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Tissue Expander." This draft guidance document describes a means by which the tissue expander device type...  

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