federal_register: 2014-21816

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-21816 Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices Proposed Rule The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs. 2014-09-15 2014 9 https://www.federalregister.gov/documents/2014/09/15/2014-21816/cardiovascular-devices-withdrawal-of-proposed-rule-of-reclassification-of-external-pacemaker-pulse https://www.govinfo.gov/content/pkg/FR-2014-09-15/pdf/2014-21816.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments...

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