
[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Page 54655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21544]


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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: Draft Standard 
Operating Procedure for Level 1, Immediately in Effect Guidance 
Documents on Premarket Data Issues; Availability and Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the Draft 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) draft 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), or a Humanitarian Device Exemption 
(HDE) 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 October 21, 2013.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the document. Submit electronic comments on the draft 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, Philip.desjardins@fda.hhs.gov.

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, including a Premarket Notification 510(k), a 
PMA, or an HDE 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 July 21, 2011 (76 FR 43693), CDRH issued a Standard Operating 
Procedure for ``Notice to Industry'' Letters, which outlined a similar 
process to clarify and quickly inform stakeholders of new CDRH 
expectations (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf). After 
considering the comments received on that proposal, CDRH is now 
announcing a draft SOP that meets the Center's needs and addresses 
concerns raised regarding the original ``Notice to Industry'' proposal.

II. Electronic Access

    Persons interested in obtaining a copy of the draft SOP may do so 
by using the Internet. The Draft 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 draft 
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: August 28, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21544 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P


