[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Pages 57587-57588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19864]



Food and Drug Administration

[Docket No. 2007N-0357]

Medical Device User Fee and Modernization Act; Notice to Public 
of Web Location of 2008 Proposed Guidance Development; Establishment of 
a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 is establishing 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.fda.gov/dockets/ecomments. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Deborah A. Wolf, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2350.


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 FDA's Center for Devices and 
Radiological Health (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 CDRH is 
intending to work on 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.
    We also note that CDRH's experience over the years has shown that 
there are many reasons CDRH staff cannot 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 it cannot know about in 
advance. These may involve newly identified public health issues as 
well as special control guidance documents that are necessary for the 
classification of de novo devices. It will be helpful, therefore, to 
receive comments that indicate the relative priority of different 
guidance topics to interested stakeholders.
    The Center expects that the recent initiatives it has taken to 
streamline and track guidance development will improve its capacity to 
issue more guidance documents. The posting and the establishment of a 
docket announced through this notice is one of the ways CDRH hopes to 
enhance the process. 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. 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 (see docket number found in brackets in the heading of this 
document) where comments about the list, draft language for guidance 
documents on those topics, and suggestions for new or different 
guidances may be submitted. FDA hopes this docket will become an 
important tool for receiving information from interested parties and 
for sharing this information with the public.

[[Page 57588]]

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.

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 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 
    To access the list of the guidance documents CDRH is considering 
for development in 2008, visit the FDA Web Site at http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html.

    Dated: October 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19864 Filed 10-9-07; 8:45 am]