[Federal Register Volume 75, Number 190 (Friday, October 1, 2010)]
[Notices]
[Pages 60761-60762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0270]


Medical Device User Fee and Modernization Act; Notice to Public 
of Web site Location of Fiscal Year 2011 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 60762]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the Web 
site location where it will post a list of guidance documents the 
Center for Devices and Radiological Health (CDRH) is considering for 
development. In addition, FDA has established a docket where 
stakeholders may provide comments and/or draft language for those 
topics as well as suggestions for new or different guidances.

DATES:  Submit either written or electronic comments at any time.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nancy Pirt, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. WO66, rm. 4438, Silver Spring, MD 20993, 301-796-5739.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations over the reauthorization of the Medical Device 
User Fee and Modernization Act (MDUFMA), 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. These commitments include annually 
posting a list of guidance documents that 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 guidances. This notice announces the Web site location of 
the list of guidances on which CDRH is intending to work over the next 
Fiscal Year (FY). We note that the agency is not required to issue 
every guidance on the list, nor is it precluded from issuing guidance 
documents that are not on the list. 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. We will consider stakeholder comments as we prioritize our 
guidance efforts.
    FDA and CDRH priorities are subject to change at any time. Topics 
on this and past guidance priority lists may be removed or modified 
based on current priorities. We also note that CDRH's experience over 
the years has shown that there are many reasons CDRH staff does not 
complete the entire annual agenda of guidances it undertakes. Staff are 
frequently diverted from guidance development to other activities, 
including review of premarket submissions or postmarket problems. In 
addition, the Center is required each year to issue a number of 
guidances that it cannot anticipate at the time the annual list is 
generated. These may involve newly identified public health issues as 
well as special control guidance documents for de novo classifications 
of devices. It will be helpful, therefore, to receive comments that 
indicate the relative priority of different guidance topics to 
interested stakeholders.
    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.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 28, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-24669 Filed 9-30-10; 8:45 am]
BILLING CODE 4160-01-S