federal_register: 2014-03593

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-03593 Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses Proposed Rule The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of July 6, 2012. In that document, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendment device, shortwave diathermy (SWD) for all other uses. In response to the requirements issued in 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 proposing a different action. 2014-02-20 2014 2 https://www.federalregister.gov/documents/2014/02/20/2014-03593/physical-medicine-devices-withdrawal-of-proposed-effective-date-of-requirement-for-premarket https://www.govinfo.gov/content/pkg/FR-2014-02-20/pdf/2014-03593.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 July 6, 2012. In that document, FDA proposed to require the filing of a premarket approval application (PMA) or a notice of completion...

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