Physical Medicine Devices; Withdrawal of Proposed Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses

Streszczenie

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.