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)

Page Range		50008-50009
FR Document		2015-20308

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 Issue 159 (Tuesday, August 18, 2015)

[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
CDRH-Guidance@fda.hhs.gov 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

50008 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Total burden Average hourly Total cost
Form name/activity hours wage rate * burden

Cognitive interviews (HSOPS 2.0 and supplemental items) ........................................... 90 a $35.38 $3,184.20
Pilot test and bridge study ............................................................................................... 2,297 b 34.98 80,349.06

Total .......................................................................................................................... 2,387 na 83,533.26
a Based on the weighted average hourly wage in hospitals for one physician (29–1060; $101.53), one registered nurse (29–1141; $30.22), one
general and operations manager (11–1021; $52.64), and six clinical lab techs (29–2010; $22.34) whose hourly wage is meant to represent
wages for other hospital employees who may participate in cognitive interviews
b Based on the weighted average hourly wage in hospitals for 1,981 registered nurses, 209 clinical lab techs, 176 physicians and surgeons,
and 21 general and operations managers
* National Industry-Specific Occupational Employment and Wage Estimates, May 2013, from the Bureau of Labor Statistics (available at http://
www.bls.gov/oes/current/naics4_621100.htm [for general medical and surgical hospitals, NAICS 622100]).

Request for Comments SUMMARY: The Food and Drug Division of Dockets Management (HFA–
In accordance with the Paperwork Administration (FDA) is announcing the 305), Food and Drug Administration,
Reduction Act, comments on AHRQ’s availability of the guidance entitled 5630 Fishers Lane, Rm. 1061, Rockville,
information collection are requested ‘‘Select Updates for Non-Clinical MD 20852. Identify comments with the
with regard to any of the following: (a) Engineering Tests and Recommended docket number found in brackets in the
Whether the proposed collection of Labeling for Intravascular Stents and heading of this document.
information is necessary for the proper Associated Delivery Systems.’’ FDA has FOR FURTHER INFORMATION CONTACT:
performance of AHRQ health care developed this guidance to inform the Katharine Chowdhury, Center for
research and health care information coronary and peripheral stent industry Devices and Radiological Health, Food
dissemination functions, including about selected updates to FDA’s and Drug Administration, 10903 New
whether the information will have thinking regarding certain non-clinical Hampshire Ave. Bldg. 66, Rm. 1222,
practical utility; (b) the accuracy of testing for these devices. While FDA is Silver Spring, MD 20993–0002, 301–
AHRQ’s estimate of burden (including considering more substantial updates to 796–6344, or Erica Takai, Center for
hours and costs) of the proposed the ‘‘Non-Clinical Engineering Tests and Devices and Radiological Health, Food
Recommended Labeling for and Drug Administration, 10903 New
collection(s) of information; (c) ways to
Intravascular Stents and Associated Hampshire Ave. Bldg. 62, Rm. 3226,
enhance the quality, utility, and clarity
Delivery Systems’’ guidance (http:// Silver Spring, MD 20993–0002, 301–
of the information to be collected; and
www.fda.gov/medicaldevices/ 796–6353.
(d) ways to minimize the burden of the
deviceregulationandguidance/ SUPPLEMENTARY INFORMATION:
collection of information upon the
guidancedocuments/ucm071863.htm),
respondents, including the use of I. Background
we are issuing this update on select
automated collection techniques or
sections in order to notify the industry FDA held a public workshop entitled
other forms of information technology.
in a timely manner of our revised ‘‘Cardiovascular Metallic Implants:
Comments submitted in response to
recommendations. Corrosion, Surface Characterization, and
this notice will be summarized and
included in the Agency’s subsequent DATES: Submit either electronic or Nickel Leaching’’ on March 8 and 9,
request for OMB approval of the written comments on this guidance at 2012, that provided information on
proposed information collection. All any time. General comments on Agency current practices for performing these
comments will become a matter of guidance documents are welcome at any tests (see http://www.fda.gov/
public record. time. MedicalDevices/NewsEvents/
ADDRESSES: An electronic copy of the WorkshopsConferences/
Sharon B. Arnold, ucm287535.htm). A group of
guidance document is available for
Deputy Director. download from the Internet. See the participants from industry, test
[FR Doc. 2015–20359 Filed 8–17–15; 8:45 am] SUPPLEMENTARY INFORMATION section for facilities, and academia provided
BILLING CODE 4160–90–P information on electronic access to the comments on practices for corrosion
guidance. Submit written requests for a testing and nickel ion release testing.
single hard copy of the guidance Based on the discussion at the
DEPARTMENT OF HEALTH AND document entitled ‘‘Select Updates for workshop, this guidance updates a key
HUMAN SERVICES Non-Clinical Engineering Tests and aspect of sample conditioning for pitting
Recommended Labeling for corrosion testing that is less
Food and Drug Administration burdensome, and includes additional
Intravascular Stents and Associated
[Docket No. FDA–2013–D–0920] Delivery Systems’’ to the Office of the information on when galvanic corrosion
Center Director, Guidance and Policy testing may be omitted with
Select Updates for Non-Clinical Development, Center for Devices and justification, based on information
Engineering Tests and Recommended Radiological Health, Food and Drug gained from the workshop. This
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Labeling for Intravascular Stents and Administration, 10903 New Hampshire guidance provides updates only for the
Associated Delivery Systems; Ave. Bldg. 66, Rm. 5431, Silver Spring, following topics:
Guidance for Industry and Food and MD 20993–0002. Send one self- • Pitting corrosion potential
Drug Administration Staff; Availability addressed adhesive label to assist that • Galvanic corrosion
AGENCY: Food and Drug Administration, office in processing your request. • Surface characterization
Submit electronic comments on the • Nickel ion release
HHS.
guidance to http://www.regulations.gov. This guidance provides cross-
ACTION: Notice.
Submit written comments to the references and updates to the related

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Document Created: 2015-12-15 12:04:41
Document Modified: 2015-12-15 12:04:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
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.
FR Citation		80 FR 50008

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration