[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]
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