[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Pages 70449-70450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28539]



Food and Drug Administration

[Docket No. FDA-2012-N-1021]

Medical Device User Fee and Modernization Act; Notice to Public 
of Web Site Location of Fiscal Year 2013 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the Web 
site location where the Agency will post two lists of guidance 
documents that the Center for Devices and Radiological Health (CDRH) is 
intending to publish in Fiscal Year (FY) 2013. In addition, FDA has 
established a docket where stakeholders may provide comments and/or 
propose draft language for those topics, suggest new or different 
guidance documents, and comment on the priority of topics for guidance.

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

ADDRESSES: Submit electronic comments on the proposed guidance to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-


I. Background

    During negotiations over the Medical Device User Fee Amendments of 
2012 (MDUFA III), Title II, Food and Drug Administration Safety and 
Innovation Act (Pub. L. 112-114), 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 prioritized medical device guidance documents that 
the Agency intends to publish within 12 months of the date this list is 
published each fiscal year (the ``A-list'') and a list of device 
guidance documents that the Agency intends to publish, as the Agency's 
guidance-development resources permit each fiscal year (the ``B-
list''). In addition to posting lists of prioritized device guidance 
documents, FDA has committed to updating its Web site in a timely 
manner to reflect the Agency's review of previously published guidance 
documents, including the deletion of guidance documents that no longer 
represent the Agency's interpretation of, or policy on, a regulatory 
issue, and notation of guidance documents that are under review by the 
Agency. Fulfillment of this commitment will be reflected through the 
issuance of updated guidance on existing topics, removal of guidances 
that that no longer reflect FDA's current thinking on a particular 
topic, and annual updates to A-list and B-list announced in this 
    This notice announces the Web site location of the two lists of 
guidance documents which CDRH is intending to publish during FY 2013. 
We note that the Agency is not required to publish every guidance on 
either list if the resources needed would be to the detriment of 
meeting quantitative review timelines and statutory obligations. The 
Agency is not precluded from issuing guidance documents that are not on 
either list.
    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

[[Page 70450]]

priorities. CDRH's experience in guidance development has shown that 
there are many reasons that CDRH staff may not complete the entire 
agenda of guidance documents it undertakes. Staff are frequently 
diverted from guidance development to other priority activities. In 
addition, at any time new issues may arise to be addressed in guidance 
that could not have been anticipated at the time the annual list is 
generated. These issues may involve newly identified public health 
issues as well as special control documents that are necessary for the 
classification of de novo devices.
    FDA anticipates that feedback from stakeholders, including draft 
language for guidance documents, will allow CDRH to better prioritize 
and more efficiently draft guidances that will be useful to industry 
and other stakeholders. 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 lists. FDA has established a docket where 
comments on the FY 2013 lists, draft language for guidance documents on 
those topics, suggestions for new or different guidances, and relative 
priority of guidance documents 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 under its good 
guidance practices (21 CFR 10.115(f)(5)). The CDRH lists, however, will 
be focused exclusively on device-related guidances and will be made 
available on FDA's Web site at the beginning of each fiscal year from 
2013 to 2017. To access the lists of guidance documents CDRH is 
intending to publish in FY 2013, visit FDA's Web site http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm

II. Request for Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28539 Filed 11-23-12; 8:45 am]