federal_register: 2012-15024

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-15024 Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). 2012-06-20 2012 6 https://www.federalregister.gov/documents/2012/06/20/2012-15024/gastroenterology-urology-devices-reclassification-of-implanted-blood-access-devices https://www.govinfo.gov/content/pkg/FR-2012-06-20/pdf/2012-15024.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information....

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