CDRH Seeks Industry’s Input on Guidance Documents

NEWS TRENDS

CDRH wants feedback from industry on the guidance documents it might develop in 2008. The center recently released a list of general topics and more-specific subtopics that may be developed into guidance documents in 2008.

In seeking MDUFMA reauthorization, FDA agreed to meet several goals in return for additional funding from industry. One such goal was for CDRH to annually post a list of guidance document topics under consideration. Another was to provide stakeholders with a chance to comment on or construct draft language for these topics, as well as to provide suggestions for new or different guidances. Officials hope that the docket can become an important tool in making information available to the public as well as receiving input from interested parties.

The list includes topics in various stages of review at the FDA level; some topics could simply benefit from updated guidances, some have been presented in Level 1 drafts that may be finalized after public comments are reviewed, and others have no guidance associated with them.

CDRH concedes that it will not be able to complete the entire annual agenda for numerous reasons. Input from industry, therefore, will help prioritize the development of documents as well as the allocation of resources.

The general topics are listed in the sidebar on this page. The center invites all interested parties to submit comments on the proposed guidance documents on the list to Docket 2007N-0357, which FDA established for comments on all proposed FY 2008 guidance documents. Comments can include draft language on the topics or suggestions for different guidance documents.

Interested persons may submit written or electronic comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852.

For more information, including a complete list of the proposed topics, visit www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html.

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