Medical Device User Fee and Modernization Act

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On December 29, 2015, FDA announced the web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) is intending to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket 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, comment on the applicability of guidance documents that have issued previously, and provide early input to support guidances that will be developed.

FDA also posed a number of questions for comment.  Of particular interest are questions to gather stakeholder feedback to enhance the CDRH guidance program, including:

– administrative information to include on the guidance cover page,
– guidances published in the last five (5) years that could serve as models for future guidance documents, and
– feedback on the enhanced Guidance Document Search feature on the FDA website

CDRH identifies draft/final guidance documents the Agency intends to publish in FY 2016.  FDA has also posted a list of final guidance documents that issued in 2006, 1996, 1986, and 1976, and is seeking external feedback on whether any of these final guidances should be revised or withdrawn.

Comments can be submitted through February 29, 2016.

Federal Register Notice: Click Here

CDRH Guidance Document Website: Click Here

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