[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53754-53755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25179]


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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 Location of 2010 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the Web 
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 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: Myrna Hanna, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. WO66, rm. 4436, 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 location of the 
list of guidances on which CDRH is intending to work over the next 
fiscal year. 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 third 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 specific 
docket where comments about the fiscal year 2010 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 fiscal year 
from 2008 to 2012.
    To access the list of the guidance documents CDRH is considering 
for development in 2010, 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) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that

[[Page 53755]]

individuals may submit one paper copy. Comments are to be identified 
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. Comments 
submitted to this docket may include draft guidance documents that 
stakeholders have prepared for FDA's consideration.

    Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-25179 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S