[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Pages 43693-43694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18387]



Food and Drug Administration

[Docket No. FDA-2011-N-0477]

Standard Operating Procedure for ``Notice to Industry'' Letters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the standard operating procedure (SOP) for ``Notice to 
Industry'' Letters. The SOP describes the Center for Devices and 
Radiological Health's (CDRH) process to clarify and more quickly inform 
stakeholders when CDRH has changed its expectations relating to, or 
otherwise has new scientific information that could affect, data 
submitted as part of an Investigational Device Exemption (IDE) or 
premarket submission that needs to be disseminated in a timely manner.

DATES: The Agency encourages interested parties to submit information 
and either electronic or written comments by September 19, 2011.

ADDRESSES: Submit electronic comments or information 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: Angela Krueger, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, e-
mail: [email protected].


I. Background

    The Task Force on the Utilization of Science in Regulatory Decision 
Making (the Task Force) published a Preliminary Report and 
Recommendations in August 2010. In the report, the Task Force noted 
that when new scientific information changes CDRH's regulatory 
thinking, it has been challenging for the Center to communicate the 
change and its basis to all affected parties in a meaningful and timely 
manner. The Task Force recommended that the Center make use of more 
rapid tools for broad communication on regulatory matters, including 
establishing a standard practice for sending ``Notice to Industry'' 
Letters to all manufacturers of a particular group of devices for which 
the Center has changed its expectations for data submitted as part of 
an IDE or premarket application on the basis of new scientific 
    Currently, manufacturers typically learn of changes CDRH implements 
at the time of or soon after a decision is made through individual 
engagement with the Center, often not until after they have prepared a 
premarket submission. Reviewers may implement these changes, such as 
requesting new clinical data or using a new test method, on a case by 
case basis, with immediate supervisory concurrence when it is necessary 
to protect the public health. For example, a reviewer may request that 
sponsors test their implantable device for durability because new data 
demonstrates that this type of device is prone to failure due to 
premature wear and tear of the technology. Although CDRH may issue a 
detailed guidance document, the document may not be published until a 
year or more after a branch- or division-level decision has been made 
to request the information because of the resource constraints in 
developing guidance documents.
    Therefore, CDRH believes that timely communication with industry 
about changes in regulatory expectations or new scientific information 
is important. The Task Force recommended that CDRH use ``Notice to 
Industry'' Letters in these circumstances, although not required, and 
adopt a uniform template and terminology for such letters, including 
clear and consistent language to indicate that the Center has changed 
its regulatory expectations, the general nature of the change, and the 
rationale for the change. The Task Force contemplated that CDRH could 
potentially issue ``Notice to Industry'' Letters, if such letters 
constitute guidance, as ``Level 1--Immediately in Effect'' guidance 
documents under 21 CFR 10.115(g)(2), and would open a public docket 
upon their issuance through a notice of availability in the Federal 
    This SOP was developed to address this recommendation from the Task 
Force. Where appropriate, CDRH will communicate new expectations as 
``Notice to Industry'' Guidance Letters, which will comply with Good 
Guidance Practices, or CDRH will communicate other new scientific 
information as ``Notice to Industry'' Advisory Letters. The Center will 
post both types of ``Notice to Industry'' Letters on its Web site, and 
will also use additional methods for distributing the Letters to 
identified stakeholders. When CDRH issues a ``Notice to Industry'' 
Guidance Letter concerning a change in premarket expectations that will 
affect pending

[[Page 43694]]

submissions, the Center will generally specify an additional amount of 
time for sponsors of those submissions to address the new issues. Where 
appropriate, ``Notice to Industry'' Guidance Letters would be followed 
as quickly as possible by new or revised guidance explaining the 
Center's new regulatory expectations (if any) in greater detail and 
revising the guidance where necessary in response to comments received, 
so that external constituencies have a fuller understanding of the 
Center's current regulatory thinking.

II. Submission of 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: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18387 Filed 7-20-11; 8:45 am]