[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53773-53774]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0920]


Select Updates for Non-Clinical Engineering Tests and Recommended 
Labeling for Intravascular Stents and Associated Delivery Systems; 
Draft Guidance for Industry and Food and Drug Administration Staff; 
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availability of the draft guidance entitled ``Select Updates for Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular 
Stents and Associated Delivery Systems.'' FDA has developed this 
guidance to inform the coronary and peripheral stent industry about 
selected updates to FDA's thinking regarding certain non-clinical 
testing for these devices. While FDA is considering more substantial 
updates to the ``Non-Clinical Engineering Tests and Recommended 
Labeling for Intravascular Stents and Associated Delivery Systems'' 
guidance (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm), we are 
issuing this update on select sections in order to notify the industry 
in a timely manner of our revised recommendations. This draft guidance 
is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 30, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Select Updates for Non-Clinical 
Engineering Tests and Recommended Labeling for Intravascular Stents and 
Associated Delivery Systems'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Lindsay Pack, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg.66, Rm. 1270, Silver Spring, MD 20993-0002, 301-796-5214; or 
Erica Takai, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg.62, Rm. 3226, Silver 
Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA held a public workshop entitled ``Cardiovascular Metallic 
Implants: Corrosion, Surface Characterization, and Nickel Leaching'' on 
March 8 and 9, 2012, that provided information on current practices for 
performing these tests (see http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm287535.htm). A group of participants 
from industry, test facilities, and academia provided comments on 
practices for corrosion testing and nickel ion release testing. Based 
on the discussion at the workshop, this draft guidance updates a key 
aspect of sample conditioning for pitting corrosion testing that is 
less burdensome, and includes additional information on when galvanic 
corrosion testing may be omitted with justification, based on 
information gained from the workshop. This guidance provides updates 
only for the following topics:
     Pitting corrosion potential;
     Galvanic corrosion;
     Surface characterization; and
     Nickel ion release.
    This draft guidance provides cross-references and updates to the 
related sections of the existing ``Non-Clinical Engineering Tests and 
Recommended Labeling for Intravascular Stents and Associated Delivery 
Systems'' guidance. Following the close of the comment period on this 
guidance, FDA intends to consider the comments received, revise this 
draft guidance as appropriate, and publish it in final. Simultaneously, 
FDA will issue an update to the existing guidance to add cross-
references where this selected updates guidance supersedes the existing 
recommendations. Subsequently, FDA will incorporate the elements of the 
final select updates guidance into an anticipated revision of the 
entire ``Non-Clinical Engineering Tests and Recommended Labeling for 
Intravascular Stents and Associated Delivery Systems'' guidance.
    This draft guidance also lists the relevant product codes for 
stents addressed in the guidance. Of note is that the product code NXP 
(Stent, Tibial), which is not currently listed in the existing ``Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular 
Stents and Associated Delivery Systems'' guidance, has been added. This 
product code was not created until after the current guidance was 
published, however, the recommendations in this draft guidance are 
applicable to tibial stents. Further, FDA will include this product 
code in the anticipated revision of the entire ``Non-Clinical 
Engineering Tests and Recommended Labeling for Intravascular Stents and 
Associated Delivery Systems'' guidance.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on certain non-
clinical testing for coronary and peripheral stents. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov.
    To receive ``Select Updates for Non-Clinical Engineering Tests and 
Recommended Labeling for Intravascular Stents and Associated Delivery 
Systems,'' you may either send

[[Page 53774]]

an email request to dsmica@fda.hhs.gov to receive an electronic copy of 
the document or send a fax request to 301-847-8149 to receive a hard 
copy. Please use the document number 1826 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

V. 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 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21191 Filed 8-29-13; 8:45 am]
BILLING CODE 4160-01-P