Document ID: FDA-2018-D-1775-0008
Agency: fda
Document Type: Notice
Title: Coronary, Peripheral, and Neurovascular Guidewires— Performance Tests and Recommended Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-10-10T04:00Z

[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54609-54611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1775]

Coronary, Peripheral, and Neurovascular Guidewires--Performance 
Tests and Recommended Labeling; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Coronary, Peripheral, 
and Neurovascular Guidewires--Performance Tests and Recommended 
Labeling.'' This guidance provides recommendations for the information 
and testing that should be included in premarket submissions for 
guidewires intended for use in the coronary vasculature, peripheral 
vasculature, and neurovasculature.

DATES: The announcement of the guidance is published in the Federal 
Register on October 10, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

[[Page 54610]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1775 for ``Coronary, Peripheral, and Neurovascular 
Guidewires--Performance Tests and Recommended Labeling.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests 
and Recommended Labeling'' to the Office of Policy, 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.

FOR FURTHER INFORMATION CONTACT: Nicole Goodsell, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2309, Silver Spring, MD 20993-0002, 240-
402-6600.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Coronary, Peripheral, and Neurovascular 
Guidewires--Performance Tests and Recommended Labeling.'' This guidance 
updates and clarifies performance testing and labeling recommendations 
to support a premarket notification (510(k) submission) for guidewires 
intended for use in the coronary vasculature, peripheral vasculature, 
and neurovasculature. The recommendations reflect current review 
practices and are intended to promote consistency and facilitate 
efficient review of these submissions. This guidance is also intended 
to assist industry in designing and executing appropriate performance 
testing to support a premarket notification and provides 
recommendations for content and labeling to include in the submission. 
FDA considered comments received on the draft guidance that appeared in 
the Federal Register of June 15, 2018 (83 FR 27998). FDA revised the 
guidance as appropriate in response to the comments. This guidance 
supersedes ``Coronary and Cerebrovascular Guidewire Guidance,'' dated 
January 1995 (available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf).

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 coronary, peripheral, and neurovascular 
guidewires performance tests and recommended labeling. 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 statutes and regulations. This guidance 
is not subject to Executive Order 12866.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy

[[Page 54611]]

of ``Coronary, Peripheral, and Neurovascular Guidewires--Performance 
Tests and Recommended Labeling'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 16007 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

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  21 CFR part; guidance; or FDA
              form                       Topic          OMB control No.
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807, subpart E..................  Premarket                    0910-0120
                                   notification.
812.............................  Investigational              0910-0078
                                   Device Exemption.
``Requests for Feedback on        Q-submissions......          0910-0756
 Medical Device Submissions: The
 Q-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809...............  Medical Device               0910-0485
                                   Labeling
                                   Regulations.
820.............................  Current Good                 0910-0073
                                   Manufacturing
                                   Practice (CGMP);
                                   Quality System
                                   (QS) Regulation.
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    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22194 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P