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October 21, 2009

FDA Issues Draft Guidance on Medical Device User Fee and Modernization Act

The Food and Drug Administration (FDA) gave notice to the public of a Proposed Guidance Development on the Web for the Medical Device User Fee and Modernization Act of 2010.

According to the Federal Register, the FDA agreed, in return for additional funding from industry, to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly.

During negotiations over the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), the FDA made commitments to include annually posting a list of guidance documents that the Center for Devices and Radiological Health (CDRH) is considering for development and providing stakeholders an opportunity to provide comments and/or draft language for those topics, or suggestions for new or different guidance’s.

The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CDRH has already issued level 1 drafts that may be finalized following review of public comments. The CDRH list will be focused exclusively on device-related guidances. The FDA requests that comments from stakeholders indicate the relative priority of different guidance topics to interested stakeholders.

The FDA has established a specific docket where comments about the fiscal year 2010 list, draft language for guidance documents on those topics, and suggestions for new or different guidances may be submitted on the FDA Web site.

Comments may be submitted at any time to http:// www.regulations.gov. Identify comments with Docket No. FDA–2007–N–0270.

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