What Guidance Documents Do You Want FDA to Publish?What Guidance Documents Do You Want FDA to Publish?

Through feedback from stakeholders, including draft language for guidance documents, CDRH expects to be able to better prioritize and more efficiently draft guidances that will be useful to industry and other stakeholders. This will be the fourth annual list CDRH has posted. FDA intends to update the list each year.

FDA invites interested persons to submit comments on any or all of the guidance documents on the list. FDA has established a docket where comments about the FY 2011 list, draft language for guidance documents on those topics, and suggestions for new or different guidances may be submitted (see ADDRESSES). FDA believes this docket is an important tool for receiving information from interested parties and for sharing this information with the public. Similar information about planned guidance development is included in the annual agency-wide notice issued by FDA under its good guidance practices (21 CFR 10.115(f)(5)). This CDRH list, however, will be focused exclusively on device-related guidances and will be made available on FDA's Web site prior to the beginning of each FY from 2008 to 2012.

To access the list of the guidance documents CDRH is considering for development in FY 2011, visit the FDA Web site

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm