federal_register: 2011-26625

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-26625 Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the external pacemaker pulse generator 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). 2011-10-17 2011 10 https://www.federalregister.gov/documents/2011/10/17/2011-26625/cardiovascular-devices-reclassification-of-external-pacemaker-pulse-generator-devices https://www.govinfo.gov/content/pkg/FR-2011-10-17/pdf/2011-26625.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the external pacemaker pulse generator preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new...

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