Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2015 Proposed Guidance Development

Resumo

The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) is intending to publish in Fiscal Year (FY) 2015. In addition, FDA has established a docket, identified in brackets in the heading of this document, where stakeholders may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, and comment on the applicability of guidance documents that have issued previously.