80 FR 50008 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

The Food and Drug Administration (FDA) is announcing the availability of the 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.

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50008-50009]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20308]


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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; 
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 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.

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

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Select Updates for Non-Clinical Engineering Tests and Recommended 
Labeling for Intravascular Stents and Associated Delivery Systems'' to 
the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.
    Submit electronic comments on the 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: Katharine Chowdhury, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave. Bldg. 66, Rm. 1222, Silver Spring, MD 20993-0002, 
301-796-6344, 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 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
 Nickel ion release

    This guidance provides cross-references and updates to the related

[[Page 50009]]

sections of the existing ``Non-Clinical Engineering Tests and 
Recommended Labeling for Intravascular Stents and Associated Delivery 
Systems'' guidance.
    In the Federal Register on August 30, 2013 (78 FR 53773), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by September 30, 2013. Four sets of 
comments were received and, in general, were supportive of the 
guidance. There were multiple comments regarding the need for 
clarification of acceptance criteria and the desire for a flow chart to 
visualize the overall testing paradigm described in the guidance 
update. In response to these comments, FDA revised the guidance 
document to include more specific information on acceptance criteria 
for pitting corrosion and surface oxide properties, as well as a flow 
chart. General concerns were noted that the guidance modifications 
might be interpreted to be more burdensome. However, the addition of 
the flowchart is intended to clarify when testing beyond pitting 
corrosion testing should be considered, and based on prior experience, 
it is anticipated that few stents will need further assessment. In 
addition, there were several comments regarding the lack of utility of 
post-fatigue pitting corrosion assessment. In response to these 
comments, as well as discussions at the March 2012 workshop, FDA has 
removed the suggestion to consider post-fatigue pitting corrosion 
testing when damage to samples is noted due to fatigue testing. There 
was also a comment that the 60-day suggested duration for nickel 
release may be unnecessarily long and burdensome, and in response, FDA 
has reduced the minimum duration to 30 days if the release rate falls 
below a predetermined level based on toxicological risk assessment.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on certain non-clinical testing for coronary 
and peripheral stents. It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Select Updates for Non-
Clinical Engineering Tests and Recommended Labeling for Intravascular 
Stents and Associated Delivery Systems '' may send an email request to 
[email protected] to receive an electronic copy of the 
document. 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 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20308 Filed 8-17-15; 8:45 am]
BILLING CODE 4164-01-P