[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Page 16801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Center for Devices and Radiological Health: Standard Operating 
Procedure for Level 1, Immediately in Effect Guidance Documents on 
Premarket Data Issues; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the Standard Operating Procedure (SOP) for Level 1, 
Immediately in Effect (IIE) Guidance Documents on Premarket Data 
Issues. The SOP describes the Center for Devices and Radiological 
Health's (CDRH's or the Center's) 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, including a Premarket Notification (510(k)), a 
Premarket Approval (PMA), a Humanitarian Device Exemption (HDE), or 
combination products containing a device constituent part for which 
CDRH has jurisdiction that needs to be disseminated in a timely manner.

DATES: Submit either electronic or written comments on this SOP at any 
time. General comments on Agency SOP documents are welcome at any time.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the SOP. Submit electronic comments on the SOP 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. Identify comments with the 
docket number found in brackets in the heading of this document.

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-
796-5678, [email protected].

SUPPLEMENTARY INFORMATION:

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 communicating to all manufacturers 
of a particular group of devices for which the Center has changed its 
regulatory expectations on the basis of new scientific information.
    Currently, manufacturers typically learn of changes CDRH implements 
regarding what data or how to gather specific data in support of an IDE 
or premarket submission at the time of or soon after a decision is made 
through individual engagement with the Center, often not until after 
they have prepared that 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 demonstrate 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.
    CDRH believes that timely communication with industry about changes 
in premarket regulatory expectations is important. FDA's Good Guidance 
Practices regulation provides a mechanism for communicating and 
implementing certain changes in regulatory expectations quickly, 
without requiring prior public comment. Under 21 CFR 10.115(g)(2), FDA 
may issue a Level 1, IIE Guidance Document when prior public 
participation is not ``feasible or appropriate.'' Under these 
circumstances, CDRH intends to use the procedures described in Sec.  
10.115(g)(2) to issue guidance documents addressing changes in 
premarket regulatory expectations. CDRH has developed this SOP to 
facilitate issuance of such guidance documents.
    On September 5, 2013 (78 FR 54655), CDRH issued a draft SOP that 
meets the Center's needs and addresses concerns raised regarding an 
original ``Notice to Industry Letters'' proposal (July 21, 2011, 76 FR 
43693). Interested persons were invited to comment by October 21, 2013. 
Three comments were received with suggestions pertaining to the 
administrative process and policies regarding IIE guidances. In 
response to these comments, FDA revised the SOP to clarify the 
processes and policies as appropriate. This document will supersede the 
``Draft Standard Operating Procedure for Level 1, Immediately in Effect 
Guidance Documents on Premarket Data Issues'' issued on September 5, 
2013.

II. Electronic Access

    Persons interested in obtaining a copy of the SOP may do so by 
using the Internet. The Standard Operating Procedure for Level 1, 
Immediately in Effect Guidance Documents on Premarket Data Issues is 
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf. The SOP is 
also available from http://www.regulations.gov and can be located using 
the docket number found in brackets in the heading of this document.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06611 Filed 3-25-14; 8:45 am]
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